This article is an introductory look at what exactly is a pFMEA or Process Failure Modes and Effects Analysis, and some ideas on how to use them as part of a living breathing risk management system.
I recently had someone ask for help understanding the
process FMEA a little better. I can’t blame them because I was lost the first
time I tried to fill out a form for one. It can be a confusing and overwhelming
if you have never seen one before.
First things first, what is a pFMEA-
FMEA= Failure Modes and Effects Analysis
A lower-case letter will come before the FMEA, and that denotes the ‘what’, of what the failure is that is being analyzed. A pFMEA will often be examining process failures where a dFMEA might evaluate design failures. (dFMEA’s can be confusing as well, Robert Packard created a training on how to document risk management activities without using one in his Death of the dFMEA Webinar)
Some systems capitalize all the letters. Some capitalize
none. That is not what is important as long as it is consistent throughout your
system. Everyone should be able to easily understand that whatever variation of
pfmea is used it means “process failure modes and effects analysis”.
What does a pFMEA do?-
A pFMEA will break down your manufacturing process into its individual steps and methodically examine them for potential risks or failures. For companies that utilize ourTurn-Key Quality Management System, FRM-025 process Failure Modes and Effects Analysis can be used as a template.
For this example, we will look at receiving inspection of
injection molded casing parts for a medical device. This receiving inspection
includes a manual inspection of 10 randomly selected parts out of each delivery
of 100 using an optical overlay.
This area as the section title suggests is the process step. When looking at the process as a whole the pFMEA will break it down into each and every step included in that process. This area is simply that individual step that is going to be examined.
The Process Step, or item function depending on what your form uses for this scenario is going to be part of the random sampling for manual inspection of the received parts using an optical overlay. Our example is going to be the backlighting element of the optical overlay display. The backlighting element will illuminate the inspected part against the template to verify that the part is within specific dimension criteria.
Potential Failure Modes-
A failure mode is a way in which that process step might fail. since it is failure modeS, it needs to be considered that there may be more than one way for the process step to fail. Do not be fooled that because this box on the form has been filled in that the pFMEA will be complete. A thorough examination of all of the possible failures should be investigated.
Our example in this process requires the backlighting element to illuminate a visual template over the parts. The light not illuminating properly is a potential failure mode of this process.
Potential Effects of Failure-
the potential effects of the failure is a look into what the ramifications would be if that failure for that process step actually happened.
In our scenario one of the potential effects of the lighting not functioning properly is that parts outside of the designated sizing acceptance criteria may be accepted rather than rejected as non-conforming parts.
The next area is the first area that requires an estimated grading of the failure. That is ‘Severity’ which is abbreviated as S. There is a scale provided in the ratings section of FRM-025 that outlines the numbering system that Medical Device Academy uses.
In this case our example is using molded plastic pieces of the outside casing of a medical device. Pieces that are too large or too small will not fit when making the final assembly of the device. These plastic pieces do not happen to be patient contacting, and do not affect the function of the device.
The evaluation of this failure is determined to have no
potential affect on patient safety or increase any potential for risk of harm,
therefore the severity is assigned as a ‘business risk’ meaning that it bears
no risk for the user or the patient. This makes the Severity Score 0.
Causes of Failure-
This column is exactly that. What might cause this identified failure to happen? In our example might be the light bulbs in the overlay machine may slowly burn out over time with use. This burnout causes the potential failure.
If the bulb is expected to only have a lifetime of 100 hours,
then the more hours the bulb is used the more dim the light may become. A
slowly dimming light decreases the sharpness of the overlay template and our
parts that are supposed to have a + or – size criteria of 10% now have a fuzzy
template that in reality changes the overlay to show closer to + or – 13%. Now
parts that are too small or too large may be accepted.
This grading criteria is also found in the Ratings section
of FRM-025. This is how often the failure is expected to occur. How often will
the lighting element of our optical overlay fail to function in the appropriate
manner for this cause?
Hopefully not very often. In fact, regularly scheduled
maintenance and calibration of the overlay machine could prevent this from ever
happening in the best-case scenario. Our evaluations determine that the
probability of this happening is low. However, since we cannot be certain it
will never happen the potential for this risk exists and makes the Occurrence
score a 4.
Current Process Controls-
What is currently being done to control this risk? Our
example uses regularly scheduled maintenance and calibration to prevent bulb
burnout effecting the overlay.
Our current process is based off of routine maintenance and
visual inspection. This means that the bulb burnout is something that is
visually inspected for and visual inspections for detectability on the rating
scale are graded as 8. This chart is found in the Ratings Section of FRM-025.
RPN (Risk Priority Number)-
This is a number that is found by multiplying the Severity,
by the Probability, by the Detectability. In our example the numbers RPN
is 0X4X8=32 for an RPN of 32 which is
Below is a short video explaining the math behind calculating the Risk Priority Number
What if anything can be done to improve this process? In our
example a recommended action may be to transfer from visual only inspections to
verification of light output by meter. This makes the Detectability of the
failure measurable by meter or gage which is a detectability score of 4.
This changes the RPN now to 0X4X4=16
The pFMEA shouldn’t be a solo thing-
If it can be avoided this type of analyisis should be done by a multidisciplinary team. Sometimes in smaller companies people end up having to wear more than one hat. There are many entrepreneurs that have to function as the CEO/CFO/Design Engineer/RA/QA manager.
Ideally a team approach should be used if feasable. Have the management level staff who have ownership of the processes participating in this analysis. They should know the process more intimately than anyone else in the company and should have more insight into the possible failure modes of the processes as they have likely seen them first hand. They are also the type of employee who would know the types of recomended actions to control the risk of those failures as well.
The pFMEA should also be a living document-
As new failure modes are discovered they should be added to your pFMEA. A new failure mode might be discovered through a CAPA because the process had an actual failure that was not originally analyzed. Take an instance like that as an opportunity for improvement and to update your pFMEA as part of a living breathing risk management system. Also use this as a time to re-brainstorm potentially similar failure modes that may not have been considered previously so that they can be controlled before they happen.
If you took the time to watch the video above it is also mentioned that in some instances the very first FMEA must be based off of estimates because there is no data. Managers, and engineers may be forced to estimate the probability of occurence. If that is the case the FMEA should be updated in the future to adjust the (O) score to reflect what is occuring in actuality based off of real data and not the theoretical data that was used for the initial estimate.
On August 9, 2019 three generations of my family left Glastonbury, CT on a two week hiking expedition to complete three of the highest peaks in the USA.
Our plan for the hiking expedition was to hike four of the highest peaks. My father, Bob Packard (age 77), is trying to complete all 50 of the highest peaks in each of the United States. For this trip we planned to hike the following peaks:
Wheeler Peak – New Mexico
Kings Peak – Utah
Borah Peak – Idaho
Granite Peak – Montana
Bailey Packard (18), Noah Packard (20), Rob Packard (47) and Bob Packard (77) started on Friday, August 9 from Glastonbury, CT.
Then we drove West….for a really long time. On Saturday, August 10 we stopped at the Waffle House.
Then we got back in the car…
Finally, on Sunday, August 11 we arrived in at the base of Wheeler Peak. We decided to hike it that day despite not acclimating to the altitude and not sleeping in two days.
Then we headed back across the ridge and down to the car. The evening we drove to Colorado and slept. The following morning, Monday, August 12, we drove through Colorado…
That evening we arrived at Henry’s Fork Trail Head in Utah several hours after dark. We pitched tents in the parking area, and slept for the night. In the morning, Tuesday, August 13, we woke to ice on our tents. Then we began the long hike into valley (see Bailey’s video above).
We were all carrying too much gear, and we needed some rest.
While we enjoyed the view of the valley…
Later we saw a couple of moose (Bailey got close enough for a selfie).
We slept the night just below Gun Sight Pass, and then headed up Kings Peak in the morning of Wednesday, August 14.
Another spectacular view…
Then we headed back across the ridge (very challenging and exposed).
That afternoon Bailey got lost, but we found him back at the tents several hours later just before dark. Noah was exhausted and took a nap in the middle of the Gun Sight Pass. We all slept well, and hiked back to the car in the morning of Thursday, August 15.
Then we drove to Idaho Falls, and we had all you can eat steak at Stockman’s.
We took at rest day on Friday, August 16. On Saturday it was perfect weather and we drove to Borah Peak in Idaho–just two hours Northwest from Idaho Falls. We arrived just after 6am and began hiking as the sun rose.
Now I understand why Wheeler was rated a 1+ in difficulty, Kings Peak was rated a 2+ in difficulty and Borah is 3+ in difficulty. There is a 2,000+ foot cliff on both sides of a goat path across a knife edge. There is sharp, jagged shale everywhere and no trees. Winds are fierce, and it’s not a windy day. Temperatures were in the low 40s. I decided to “chicken out” just before we got to “Chicken Out Ridge”.
Where Rob waited for the others.
The ice bridge was not expected, and dozens of weekend hikers with no experience were trying to crawl across the ice. Bailey used his knife for extra grip on the ice. Bob was almost knocked off the mountain by a falling boulder and they made it to the peak…waiting for Bailey’s pictures to be added later.
Then we all headed down the mountain.
The following day, Sunday, August 18, we drove home…our feet were too sore to attempt Granite Peak. But along the way, we stopped on Monday, August 19 at Portillo’s for
This article describes what a gap analysis is in the context of managing your quality system when standards and regulations are updated.
What is a Gap Analysis? An introductory look.
Well, that depends on the context. The dictionary definition is “A technique that businesses use to determine what steps need to be taken in order to move from its current state to its desired, future state. Also called need-gap analysis, needs analysis, and needs assessment.” (http://www.businessdictionary.com/definition/gap-analysis.html).
For the most part this is correct, but we need to tweak it just a little bit to fit better into our regulatory affairs niche, specifically medical device manufacturers. A gap Analysis for a financial investment, or an advertising firm will be very different than one for a medical device distributor. It might even be better served to be called a Compliance Assessment/Gap Analysis, but I am sure someone else has thought of that long before me.
For our purposes the Gap Analysis is formal comparative review of an internal process or procedure against a standard, good practice, law, regulation, etc. This blog article will be an introductory look into that process.
What are the two BIG goals of a Gap Analysis?
It sounds like a simple exercise, but the Gap Analysis or GA for short, can have two very different but complimentary functions. Rather than simply hunting for areas of non-compliance the first goal is to find and demonstrate areas of compliance.
The second more obvious goal is to find the gaps between the process and the regulatory requirements they are being compared against.
Why is demonstrating compliance important?
Because this is a formal documented review, a Gap Analysis provides documentation in a traceable manner of meeting the requirements that have been laid out. That traceability is important because it allows anyone to read the report, see the requirement and locate the area of the procedure that demonstrates conformity with that requirement.
The report itself is an objective tool, not something that is meant to be a witch hunt. The Gap Analysis will compare document contents. If you want to verify that the entire process is fully compliant you will need to dig deeper and observe if the activities laid out within the procedure are being performed per the procedure instructions. It is possible to draft procedures that are compliant with text requirements but non-compliant in the manner that the actions are actually being performed and documented.
What about gaps?
The gaps, or areas of non-compliance highlight opportunities for improvement, if there are any. A Gap Assessment may not find any gaps and present a report that clearly and neatly outlines and explains how each regulatory requirement is being met.
If there are any gaps identified that does not mean that there is cause for concern. This should be viewed rather as an opportunity for improvement. Standards and procedures change over time and it is natural that procedures and processes will have to change with them.
In fact, the very act of the Gap Analysis shows that there is a documented effort towards continual improvement as long as the gaps are addressed.
Addressing the Gaps
The report is ideally the first and last step and you have a wonderful piece of paper to show that someone checked, and all of the required areas are being met. However, this is not always the case. When there are gaps, they must be filled.
Addressing a gap should happen in a traceable manner, one that shows it was identified, acknowledged and then how it was fixed. Something that might be addressed through a CAPA process, but that is a topic for a different time.
The Compliance Assessment/Gap Analysis is a singular tool used in the overall maintenance of a quality system. Its actions and performance are similar to a simplified type of audit, but the Gap Analysis itself is not going to replace your regularly scheduled audit activities. However, it will help you monitor and keep your fingers on the overall pulse of your quality system. This is also especially helpful in situations where standards and regulations are updated, and your quality system needs to be evaluated and updated accordingly.
This article is a reminder that the new FDA User Fees FY2020 have been announced, and it is time for you to re-apply for small business qualification.
FDA User Fees FY2020 = 5.85% Increase in 510(k) User Fee
In 2016 the FDA and industry negotiated revised user fees to achieve faster decision timelines. In return for higher user fees, the FDA promised faster decision timelines. This agreement ultimately became the Medical Device User Fee Amendments of 2017 (i.e., MDUFA IV). This new higher fee structure was implemented in FY 2018 (i.e., October 2017). The MDUFA IV agreement also included plans for inflation adjustments each year. Therefore, on July 31, 2019 the FDA announced the new inflation-adjusted pricing for FDA User Fees FY2020 in the Federal Register.
This new pricing for the medical device user fees is published in Table 5 of the July 31st announcement. All of the fees increased. The 510k standard user fee, for example, increased from $10,953 to $11,594–and increase of 5.85%. The FDA also sent out an email update about the increased user fees last week.
Prior to FY 2019, companies were not able to apply for small business status until October 1. However, in August 2018 the FDA changed the forms, guidance and policies to allow companies to apply for small business status as soon as August 1. The form also now allows the applicant to fill-in the applicable fiscal year. This eliminates the need for the FDA to update the application form each year.
The approval of small business status by the FDA can take up to 60 days. Therefore, every small business planning to submit a regulatory submission to the FDA in FY 2020 should apply for small business status now–instead of waiting until October or when they are planning to submit. This will reduce the possibility of a company needing to submit their submission before they have been qualified by the FDA as a small business and paying the higher standard user fee.
When you submit your application, make sure that you send an original application, because the FDA will not accept a copy–especially for international submissions. Companies located outside the USA, or companies with subsidiaries outside the USA, must obtain verification of the taxes paid by the national tax authority in each country. This extra step makes it even more critical for device companies to start the application process immediately.
In parallel with these annual user fee increases, Medical Device Academy increased our flat-fee pricing for preparing submissions on August 1. The new higher consulting fee increased from $12,000 to $14,000. This fee does not include our flat-fee for each FDA eCopy of $150/eCopy–typically averaging $600/project. However, we now include any time required to response to RTA Hold Letters and requests for additional Information. This typically ranges from 5-10 hours of consulting time at $300/hour. Therefore, the net change is from $14,250 to $14,600 (i.e., an increase of 2.46%). More importantly, it makes the total cost of hiring our firm more predictable and less time consuming for our firm to quote. Our firm’s hourly rates have not changed.
If you are interested in learning more about applying for small business status, please visit our webinar page on this topic or contact us for help. If you are interested in our new pricing, please click on the download button found on our home page.
This article explains what to look at and what to look for when you are auditing technical files to the new Regulation (EU) 2017/745 for medical devices.
Next week, August 8th @ Noon EDT, you will have the opportunity to watch a live webinar teaching you what to look at and what to look for when you are auditing technical files. Technical files are are the technical documentation required for CE Marking of medical devices. Most quality system auditors are trained on how to audit to ISO 13485:2016 (or an earlier version of that standard), but very few quality system auditors have the training necessary to audit technical files.
Why you are not qualified for auditing technical files
If you are a lead auditor, you are probably a quality manager or quality engineer. You have experience performing verification testing and validation testing, but you have not prepared a complete technical file yourself. You certainly can’t describe yourself as a regulatory expert. You are a quality system expert. A couple of webinars on the new European regulations is not enough to feel confident about exactly what the content and format of a technical file for CE marking should be.
Creating an auditing checklist
Most auditors attempt to prepare for auditing the new EU medical device regulations by creating a checklist. The auditor copies each section of the regulation into the left column of a table. Then the auditor plans to fill in the right-hand columns of the table (i.e., the audit checklist), with the records they looked at and what they looked for in the records. Unfortunately, if you never created an Essential Requirements Checklist (ERC) before, you can only write in your audit notes that the checklist was completed and what the revision date is. How would you know if the ERC was completed properly?
In addition to the ERC, now called the Essential Performance and Safety Requirements (i.e., Annex I of new EU regulations), you also need to audit all the Technical Documentation requirements (i.e, Annex II), all the Technical Documentation on Post-Market Surveillance (i.e., Annex III), and the Declaration of Conformity (i.e., Annex IV). These four annexes are 19 pages long. If you try to copy-and-paste each section into an audit checklist, you will have a 25-page checklist with more than 400 things to check. The end result will be a bunch of check boxes marked “Yes” and your audit will add no value.
Audits are just samples
Every auditor is trained that audits are just samples. You can’t review 100% of the records during an audit. You can only sample the records as a “spot check.” The average technical file is more than 1,000 pages long, and most medical device manufacturers have multiple technical files. A small company might have four technical files. A medium-size company might have 20 technical files, and a large device company might have over 100 files. (…and you thought the 177-page regulation was long.)
Instead of checking a lot of boxes “Yes,” you should be looking for specific things in the records you audit. You also need a plan for what records to audit. Your plan should focus on the most important records and any problem areas that were identified during previous audits. You should always start with a list of the previous problem areas, because there should be corrective actions that were implemented and effectiveness of corrective actions needs to be verified.
Which records are most important when auditing technical files?
I recommend selecting 5-7 records to sample. My choices would be: 1) the ERC checklist, 2) the Declaration of Conformity, 3) labeling, 4) the risk management file, 5) the clinical evaluation report, and 6) post-market surveillance reports, and 7) design verification and validation testing for the most recent design changes. You could argue that my choices are arbitrary, but an auditor can always ask the person they are planning to audit if these records would be the records that the company is most concerned about. If the person has other suggestions, you can change which records you sample. However, you should try not to sample the same records every year. Try mixing it up each year by dropping the records that looked great the previous year, and adding a few new records to your list this year.
What to look for when auditing technical files
The first thing to look for when you audit records: has the record been updated as required? Some records have a required frequency for updating, while other records only need to be updated when there is a change. If the record is more than 3 years old, it is probably out of date. For clinical evaluation reports and post-market surveillance reports, the new EU regulations require updating these reports annually for implantable devices. For lower risk devices, these reports should be updated every other year or once every three years at a minimum.
Design verification and design validation reports typically only require revisions when a design change is made, but a device seldom goes three years without a single change–especially devices containing software. However, any EO sterilized product requires re-validation of the EO sterilization process at least once every two years. You also need to consider any process changes, supplier changes, labeling changes and changes to any applicable harmonized standards.
Finally, if there have been any complaints or adverse events, then the risk management file probably required updates to reflect new information related to the risk analysis.
Which record should you audit first?
The ERC, or Essential Performance and Safety Requirements checklist, is the record you should audit first. First, you should verify that the checklist is organized for the most current regulations. If the general requirements end with section 6a, then the checklist has not been updated from the MDD to the new regulations–which contains 9 sections in the general requirements. Second, you should make sure that the harmonized standards listed are the most current versions of standards. Third, you should make sure that the most current verification and validation reports are listed–rather than an obsolete report.
This article identifies one overlooked secret to accelerating design projects that you can implement immediately and it will work on every project.
You would love to cut a few weeks off the launch schedule for your device. If you had a magic wand, what would you wish for? The trick to accelerating design projects is not an unlimited budget, hiring ten more engineers, or paying a Nationally Recognized Testing Laboratory (NRTL) to only work for you.
I know a secret for accelerating design projects that will work, but first you need to understand why projects take as long as they do. Yes, I worked on a few design teams, but I learned the most from watching companies make mistakes that created delays and cost them time. Sterility tests can not be made shorter, guinea pig maximization tests (GPMT) can’t be completed in four weeks, and your electrical safety testing report will not be delivered when the lab promised it would be.
Accelerating design projects by preventing testing delays
The primary source of delay is not that testing is delayed, but rather the testing is not started as early as it could be. Some managers believe that the solution is to use a Gantt chart. Unfortunately, Gantt charts are not a solution. Gantt charts are just tools for monitoring projects. There is much more to project management. If you forget to do just one test, your entire project will be delayed until that test is finished. Therefore, making sure you identify every required test is an essential early project task–even before you start designing your device. You also need to update the plan when things change.
Start with a generic template for your testing plan
Our firm has a template for a device testing plan that we use for every pre-submission request. In fact, getting help creating your testing plan is one of the most important reasons to hire our firm to help you with a pre-submission request. Surprisingly, our template is more comprehensive than most design plans. What makes our plan surprising is that it’s a generic testing plan that I created in 30 minutes. If you would like it, just email me at firstname.lastname@example.org. We also have an updated template for combined design and risk management plans.
I’m not suggesting that our plan template already includes every single safety and performance test. Our testing plan does not include everything. However, we spend several hours looking for applicable guidance documents and researching the testing requirements for your device. Then we add the requirements we find to your customized testing plan in the pre-submission request.
Basics of shortening the critical path
If your testing plan includes 100% of the safety and performance tests that you need, your project will still be unnecessarily delayed. The reason for the unnecessary delay is that you are not taking advantage of the three most important timing factors:
First, do every test in parallel that you can.
Second, identify any tests that must be done sequentially.
Third, protect your critical path from further delays.
In summary, I gave you several clues to the one secret. But the one secret is simple and practical. You need someone on your team who only focuses on the testing plan. Usually every person on a design team is multitasking, but none of us can really focus when we are multitasking. As the design project manager, it would be impossible for you to focus on one task. You are a project manager of a design team, and managing a project team is inherently all about multitasking. Therefore, you need to give one person on your team the task of focusing on the testing plan throughout the entire project. It doesn’t have to be the same person during every phase of the project. In fact, by rotating who that person is, each person assigned this responsibility only needs to be dedicated for a short duration. This is a critical concept. One person must be focused on your testing plan, and that person must be dedicated to that task as long as they are responsible for focusing on your testing plan. You might even consider making a big deal out of it…
Managers are always looking for creative ways to motivate teams. Custom t-shirts are fun, you can quickly design a different t-shirt for each role on the team, everyone can wear their t-shirt to team meetings, and the testing plan t-shirt will clearly identify who has the responsibility for focusing on the secret to completing the project on schedule. You can order one of these t-shirts from us for $15. I dare you to compare the cost of a few custom t-shirts with the other solutions you were considering.
Our Testing Plan is my life T-Shirt
Please click the button to confirm that you’d like to receive the t-shirt shown in the picture. Please let us know what size you would like (M, L, XL, 2XL, 3XL). Only white t-shirts available with black graphics. We also need your shipping address. Shipping via US Postal Service is FREE. If you want the t-shirt expedited, we can ship it via FedEx to you. We will invoice you for the cost of our FedEx shipping to your location.
This article outlines an EU MDR quality plan for compliance with European Regulation 2017/745 for medical devices by the May 26, 2020 transition deadline.
Biggest MDR quality plan mistakes
Implementing an MDR quality plan is not just about updating your technical file and the procedures specific to CE Marking of medical devices. You need to make sure that you have planned to provide adequate resources for successful implementation of your plan. Resources fall into four major categories, and all four should be addressed in a formal MDR quality plan that you have reviewed and approved during a management review meeting (i.e., ISO 13485:2016, Clause 5.6.3d). First, you need to provide adequate training. Second, you need to provide adequate equipment–such as UDI printing software and an electronic quality system database. Third, you need to provide adequate personnel. Fourth, you need to revise and update your quality system procedures.
European companies concentrated enormous resources in 2018 to prepare for implementation of the EU Regulations in 2020. This may seem early, but most of those companies are realizing they should have started in 2017–immediately after Regulation 2017/745 was approved by the European Parliament and Council. In contrast, most companies in the USA were focusing on ISO 13485:2016 certification and MDSAP certification. Unfortunately, many CEOs were told that there is a “soft-transition” and they have until 2024 to implement the new regulations. While it is true that most CE Certificates issued by notified bodies will be valid until their expiration date, and that date could be as late as May 25, 2024, it is not true that companies have until 2024 implement the new regulations. Quality system requirements in Article 10 of the MDR, and compliance with the MDR for economic operators, must be implemented by May 26, 2020. Any medical devices that are being reclassified will require full implementation by May 26, 2020 as well. Finally, notified bodies cannot renew 100% of the CE Certificates on May 25, 2020 to give manufacturers the full 4-year transition for certificates. You certificate will expire based upon the certificate renewal cycle that is already established.
Required procedures for your EU MDR quality plan
You might not know that ISO 13485:2016 certification is not actually required for CE Marking of medical devices. Although ISO 13485 certification is the most popular way for companies to demonstrate quality system compliance with EU regulations, the actual requirement is to comply with the thirteen procedural requirements in Article 10 of EU Regulation 2017/745. Specifically, those thirteen procedures are:
Note: If you are interested in one of the procedures listed above that does not have a hyperlink, please contact me via email at email@example.com. The procedures are available, and the links will be provided during next two weeks. The only exception is SYS-026. That is a new procedure in draft format, and it will be the subject of a future blog. Medical Device Academy will be revising each of the above procedures for compliance with EU Regulation 2017/745 in accordance with the MDR quality plan that we have outlined in this blog article. These procedures are all compliant with ISO 13485:2016, and updates for compliance with the EU MDR will be made available at no additional charge.
Priority of requirements for MDR quality plan
There are seven major changes required for compliance with the European Regulation 2017/745. These priorities are listed in order of highest to lowest effort and cost that will be required to comply, rather than the chronological order. First, some medical devices are being reclassified. Second, new CE certificates must be issued under the new conformity assessment processes. Third, technical documentation must be updated in order to meet Annex II of Regulation 2017/745. Fourth, post-market surveillance documentation must be updated in order to comply with Annex III of Regulation 2017/745. Fifth, specific documentation must be uploaded to the Eudamed. Specifically, manufacturers must upload UDI data, labeling and periodic safety update reports (PSUR). Sixth, all economic operators must be registered with Eudamed and comply with Regulation 2017/745 or new economic operators will need to be selected. Seventh, quality system procedures will need to be updated to comply with Regulation 2017/745.
Implementation timeline for MDR quality plan
If any of your devices are being reclassified, you will need to implement all of the above changes prior to the May 26, 2020 transition date. For example, reusable medical instruments are currently Class I medical devices, and manufacturers utilize Annex VII of the MDD as the conformity assessment process. Under EU Regulation 2017/745, these reusable instruments will require notified body involvement to issue a CE Certificate. This is a lot of work to complete in 17 months (i.e., 513 days and counting), and notified bodies will have a large backlog of technical files to review for existing customers before they will be able review documentation for new customers.
If your company already has CE Certificates for your medical devices, and none of your devices are being reclassified, you will need to implement only the sixth and seventh items listed above before the May 26, 2020 deadline. Uploading information to Eudamed is likely to be extended beyond the May 26, 2020 deadline and the transition may be staggered by risk classification–just as the US FDA did for UDI implementation in the USA. The second, third and fourth changes listed above will require compliance before your existing CE Certificate(s) expire. Best-case scenario, this could be four (4) years after the transition deadline.
Today the FDA released a press release announcing plans to implement a alternate 510k pathway called the “Safety and Performance Based Pathway.”
What is the current 510k pathway for clearance of medical devices?
The current version of the 510k pathway is defined in a guidance document on substantial equivalence that was released on July 28, 2014. The pathway involves six questions that an FDA reviewer must answer before it can be determined whether a new device is equivalent to an existing device that is legally marketed in the USA. These are the 6 questions:
Is the predicate device legally marketed?
Do the devices have the same intended use?
Do the devices have the same technological characteristics?
Do the different technological characteristics raise different questions of safety and effectiveness?
Are the methods of evaluating new/different characteristics acceptable?
Does the data demonstrate substantial equivalence?
Five (5) ways the FDA strengthened the current 510k pathway
Today the FDA released an 8-page presentation summarizing five (5) ways that the FDA strengthened the current 510k pathway during the past several years. The five ways are:
Increased expectations for the content of a 510k submission
Improved consistency and thoroughness of the 510k review process
Elimination of the 510k pathway for Class III devices
Eliminated the use of > 1,000 unsafe devices as legal predicates
You may have been complaining that 510k requirements seem to change constantly. Now you have proof that the changes to the 510k pathway are part of a strategic plan implemented over the past decade. Lawyers may argue that the resulting regulations go well beyond the intent of the original 510k legislation. This is completely true. The cumulative effect of implementing dozens of 510k guidance documents is that the official interpretation of the 510k section of the Food and Drug Act now has little resemblance to the original legal intent.
The original intent of the 510k legislation was to allow competitors to copy an existing device that is legally marketed in the USA. Cumulative changes to a device that existed in 1976, eventually results in a completely new device. The word “equivalent” has been perverted to such an extent that thousands of devices now exist that do not even remotely resemble devices from 1976. The FDA recognized this around 2007, and the US device regulations began to “strengthen.”
What is basis for the Alternate 510k Pathway?
The basis for the alternate 510k pathway is submission of data that is safety and performance based instead of comparison to an older predicate. In addition, the new pathway will enable you to make comparative claims by demonstrating that the new subject device meets or exceeds the safety and performance criteria. There is also a goal to use the pathway as a potential method of harmonizing the US medical device regulatory process with other global medical device regulations. The new process, combined with improved post-market surveillance, will complement the FDA’s work on NEST by allowing the FDA to rapidly require implementation of risk controls to address identified safety issues.
What is the expected timeline for implementation of the Alternate 510k Pathway?
The alternate 510k pathway has been in development for quite some time. Jeff Shuren first announced the plan to create the alternate 510k pathway at AdvaMed’s MedTech conference in San Jose, California in September 2017. On Monday, December 11, 2017, the FDA announced that a draft guidance would be released in Q1 of 2018. On April 12, 2018 the FDA finally released the draft guidance for public comment.
The FDA intends to release a final guidance for the new alternate 510k pathway in early 2019. This pathway will initially be limited to “well-understood device types”–probably as a 510k pilot program. You can expect this new pathway to be released in a similar way to the Special 510k expansion pilot and the Quik 510k pilot. That final guidance will be released, and the pilot will begin immediately after release of the guidance.
Is this new process likely to require significant changes to future 510k submissions?
The phrase “significant changes” is subjective, but if you look at the current 20 required sections of a 510(k) submission, there is only one section that would be required to change for the new alternate 510k pathway. Specifically, section 12 is currently used for a substantial equivalence comparison. This section would not be applicable under the alternate 510k pathway. Under the alternate 510k pathway, you can expect the FDA to require at least a summary of the safety and performance data to be submitted for approval of the subject device.
Another change you can expect is that all devices submitted under the alternate 510k pathway will be required to have a benefit-risk analysis in accordance with the corresponding FDA guidance. This new guidance was released on September 25, 2018 as a draft. However, a benefit-risk analysis is required for De Novo applications, CE Marking applications and it is logical that the FDA will also require this for 510k submissions that do not rely upon equivalence to predicate device.
More Information on the Medical Device Safety Action Plan
The FDA created a webpage on its site providing information about the Medical Device Safety Action Plan. The page includes several hyperlinks to documents with more information. Below are a few of the relevant links:
The FDA also indicated that a new guidance for De Novo applications will be released in a couple of weeks. Please subscribe to our blog, and you will receive notification of a blog in response to that guidance when it is released.
This article defines the requirements for design and risk management planning that were used to create our new design plan template.
Why combine Design and Risk Management Plans into a Design Plan Template?
There are two primary reasons for combining your risk management plan with your design plan. The first reason is to reduce the number of documents you must maintain and control. The second reason is that there are different requirements for risk management during the design process and after commercial release of a new product. Therefore, you will need one risk management during the design phase, and a second risk management plan after your product is released. You can achieve this by incorporating your risk management plan with your design plan and your post-market surveillance plan. Therefore, you only need to maintain two documents instead of four.
Six requirements for your design plan?
There are no specific design planning requirements in the new European MDR, but the requirements for design planning are specified in ISO 13485:2016, Clause 7.3.2. In the previous version of ISO 13485, the requirement for a design procedure and a design plan were combined into one clause (i.e., Clause 7.3.1). Now these two requirements have been split into independent clauses. The requirement to manage the interfaces between various groups involved in the design project was removed from the requirements for design planning in the new version of the standard, but three additional requirements were added. The following sub-clauses did not change (although numbering changed):
7.3.2a) document the design and development stages
7.3.2c) document verification, validation and transfer activities required at each stage
7.3.2d) document responsibilities and authorities
First new requirement in your design plan template
The first new requirement is in Clause 7.3.2b). You are required to document the design reviews required at each stage. This does not mean that a review is required at every stage, but your plan should specify at which stages you will conduct a review. At a minimum, a final design review is required for commercial release of the device. My recommendation is to have a review at every stage for every project. If you design inputs have not changed from the previous version of the device, then the stage leading up to the approval of design inputs will be very short, and that design review meeting can be 30 minutes or less. If you make changes to your design control procedure in the middle of a project, I recommend that you maintain compliance with the existing procedure until the next design review. The design review gives you a great opportunity to document changes to the design procedure, design plan and any other adjustments to documentation that may require completion of a new version of a form.
Second new requirement in your design plan template
The second new requirement is in Clause 7.3.2e). You are required to document methods of traceability between design inputs and outputs. This is a requirement that most companies do poorly. In theory, you can use a spreadsheet to list all the design inputs and the adjacent column can list the corresponding design outputs. Many companies use an input / output / verification / validation (IOVV) diagram. You can also add user needs to this diagram. The challenge with method of documentation is that it is labor intensive to make updates. You must update the references to inputs every time a standard is updated. The outputs must be updated every time a drawing or specification is changed. Every time you update a verification or validation testing report, the diagram must be updated too.
Third new requirement in your design plan template
The third new requirement is in Clause 7.3.2f). You are required to document the resources needed at each stage–including the necessary competence of personnel. In general, companies experiencing difficulties in documenting competency for personnel, but this requires that you document competency for each person on a design project for each stage. My recommendation is to keep it simple. Tables are usually the simplest way to document this type of information. For example, you can use a three-column table: 1) role, 2) responsibility, 3) competency requirements. In general, I recommend that anyone on your design team has training on design controls and risk management. However, training and competency are not equivalent. In order to demonstrate competency, you must have prior experience documented in that area.
What is required in a Risk Management Plan?
EN ISO 14971:2012 requires a risk management plan in Clause 3.4, but there are some subtle changes needed for compliance with the new draft ISO/DIS 14971. In addition, there are new requirements in Regulation (EU) 2017/745. Specifically, in Essential Requirement 3:
(a) establish and document a risk management plan for each device;
(b) identify and analyse the known and foreseeable hazards associated with each device;
(c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
(d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
(e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
(f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4.
In our previous blog on changes to the risk management process, we identified 9 activities that should be included in your risk management plan:
This article describes updates being made to the ISO 14971 Standard in the new draft version released for comment in July 2018.
There are two versions of ISO 14971 that are currently available. The first is the international version: ISO 14971:2007. The second is the European normative version: EN ISO 14971:2012. There is also a new draft being created by the TC210 committee for release in 2019.
Explanation of the different versions of the ISO 14971 standard
In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. In 2007, the second edition of ISO 14971 was released. When new international standards are released, a European normative version is also released. The “European Norm” or EN version is intended to identify any gaps between the international standard and the requirements of the applicable European directives (i.e., the MDD, AIMD and the IVDD). These gaps historically were included in the ZA annex at the end of the EN version. However, in 2009 this annex was split into three annexes (i.e., ZA, ZB and ZC) to address each of the three directives separately. In reality, the 2009 annex only differed with regard to the directive referenced. In 2012, a new EN version was released. This new standard included 7 deviations which were controversial. These deviations were intended to identify contradictions between the directives and the international standard, but the interpretations were not agreed with by companies or most of the Notified Bodies. Ultimately, the 7 deviations were required to be addressed in the risk management files for any medical device that was CE Marked.
What changed between ISO 14971:2007 and ISO/DIS 14971:2018?
The TC210 working group assigned to update the ISO 14971 standard (JWG1) was tasked with improving guidance for implementation of ISO 14971, but the committee was also tasked with making these improvements without changing the risk management process. In addition, the committee was asked to move the informative annexes at the end of ISO 14971 from the standard to the guidance document ISO/TR 24971. Therefore, in July the committee released a draft for comment and voting. Draft versions are identified with the prefix “ISO/DIS.” The ISO/DIS 14971 standard released in July has only three annexes: A) Rationale for the requirements, B) Risk management process for medical devices, and C) Fundamental risk concepts (formerly Annex E). The other 7 annexes were moved to the draft of ISO/TR 24971. The reason stated for moving these Annexes to the guidance document was to make future revisions to the guidance easier to implement, because it is a guidance rather than a standard. However, there were also some objectionable recommendations in the informative annexes that were the subject of deviation #3—ALARP from Annex D.8 vs. “As far as possible” in the first indent of section 2 of Annex I in the MDD.
Although the committee was tasks to make improvements in the implementation of ISO 14971 without changing the process, the new draft has subtle changes in the process. Most of these changes can be identified quickly by reviewing the updated risk management flow chart provided in Figure 1. The updated flow chart now has two places where risks are evaluated. The first place is identical the original Figure 1, but now the associated section is clarified to be specific to evaluating individual risks. The second place in the flow chart is new, and specific to evaluation of overall residual risks. The draft standard also states that different acceptability criteria and methods of evaluation may be used for each evaluation phase in the process. There have also been subtle changes to the names of process phases:
Section 7.4 is now “Benefit/Risk” analysis instead of “Risk/Benefit” analysis—although the draft flow chart does not reflect this.
Section 9 is now “Risk Management Review” instead of “Risk Management Report”
Section 10 is now “Production and post-production activities” instead of “Production and post-production information”
There is also more detail in the diagram under the phases for: 1) risk analysis, 2) risk control, and 3) production and post-production activities.
Three new definitions are introduced in the draft standard: 3.2, benefit; 3.15, reasonably foreseeable misuse; and 3.28, state of the art. The section for identification of hazards, Clause 5.4, was reworded and expanded to consider the reasonably foreseeable sequences or combinations of events that can result in a hazardous situation. The draft standard now states that your risk management plan must also include a method to evaluate the overall residual risk and the criteria for acceptability of the overall residual risk. In the section for risk estimation, Clause 5.5, the draft standard states that if the probability of the occurrence of harm cannot be estimated, the possible consequences shall be listed for use in the risk evaluation and risk control. The risk control option analysis priorities in section 7.1 are updated to match the new MDR, Regulation (EU) 2017/745, nearly exactly. In section 9, risk management reports were changed to risk management review and the clause now requires determining when to conduct subsequent reviews and when to update reports. This emphasizes the requirement to continuously update risk management documentation with input from production and post-production information. This mirrors the emphasis on continuously updating post-market clinical follow-up in Regulation (EU) 2017/745, Annex XIV, Part B, Section 5; and continuously updating clinical evaluations in Regulation (EU) 2017/745, Annex XIV, Part A, Section 1.
Will ISO 14971:2019 address the 7 Deviations in EN ISO 14971:2012?
The new MDR, Regulation (EU) 2017/745, revised and clarified the wording of the essential requirements in the MDD. The MDR attempts to clarify the requirements for risk management files of CE Marked products, but the MDR remains different from the requirements of ISO 14971. Unfortunately, because the ISO/DIS 14971 was not intended to change the risk management process of ISO 14971:2007, there will continue to be “deviations” between the MDR and standard.
Some people have tried use ISO/TR 24971, the risk management guidance, as the official interpretation of how the risk management standard. However, the guidance is also a product of the TC210 committee, and it does not meet all requirements of the MDD or the MDR.
The new draft does, however, include changes that address some of the deviations in EN ISO 14971:2012. Below, each of the 7 deviations are listed and hyperlinks are provided to other articles on each individual deviation.
Negligible Risks – The word “negligible” was only in one location in the body of the standard as a note referring to Annex D.8. In the draft, Annex D was removed and relocated to ISO/TR 24971, and the note was eliminated from Clause 3.4—now Clause 4.4 in the draft. This deviation should be fully resolved by the draft.
Risk Acceptability – Clause 7 was renumbered to Clause 8 in the draft, but the title of this clause was also changed from “Evaluation of overall residual risk acceptability” to “Evaluation of overall residual risk.” However, if you read the Clause it still refers to determining acceptability of risks. In note 2 of Annex ZA of the draft, it states that determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. This deviation should be fully resolved by the draft.
ALARP vs. “As far as possible” – The European Commission believes that the concept of “ALARP” implies economic considerations, and some companies have used economics as a reason for not implementing certain risk controls. ALARP was eliminated from the notes in the risk management plan clause and by moving Annex D.8 to ISO/TR 24971 and adding note 1 in Annex ZA. This deviation should be fully resolved by the draft.
Benefit/Risk Analysis – The contradiction in requirements between the International Standard and the MDD, as it relates to determining when a benefit/risk analysis must be conducted has not been updated. This deviation is not resolved by the draft. Companies that CE Mark products will need to perform a benefit/risk analysis for all residual risks and all individual risks—despite the wording of the standard.
Risk Control – The contradiction in requirements between the International Standard and the MDD, as it relates to determining when risk controls must be implemented. The International Standard gives companies the option to avoid implementation of risk controls if the risk is acceptable, while the MDD requires that risk controls be implemented for all risks unless the risk controls create additional risks that increase risks or the risk controls do not actually reduce risks further. This deviation is not resolved by the draft. Companies that CE Mark products will need to implement risk controls for all individual risks—despite the wording of the standard.
Risk Control Options – The intent of Clause 6.2 in ISO 14971:2007 was likely to be the same as the MDD. However, the European Commission identified the missing word “construction” as being significant. Therefore, to prevent any misunderstandings, the TC210 committee copied the wording of Regulation (EU) 2017/745. This deviation should be fully resolved by the draft.
IFU Validation – Again, to prevent any misunderstandings, the TC210 committee copied the wording of Regulation (EU) 2017/745. However, the examples of information for safety (i.e., warnings, precautions and contraindications) were not included. Hopefully, the final version of 3rd edition will include these examples. Clause 8, evaluation of overall residual risk, was also reworded to state, “the manufacturer shall decide which residual risks to disclose and what information is necessary to include in the accompanying documentation in order to disclose those residual risks.” This deviation should be fully resolved by the draft.
Recommendations for your Risk Management Process?
The most important consideration when establishing a risk management process for medical devices is whether you plan to CE Mark products. If you intend to CE Mark products, then you should write a procedure that is compliant with the current requirements of the MDD and future requirements of Regulation (EU) 2017/745. Therefore, the 7 deviations should be addressed. In addition, you need to maintain compliance with the current version of the Standard.
I recommend creating a process based upon the new updated process diagram in the new draft. The process should begin with a risk management plan. For you plan, you may want to create a template and maintain it as a controlled document. It could also be part of your design and development plan template, but the plan should include each of the following risk management activities:
Risk control option analysis
Risk control verification of effectiveness
Evaluation of overall residual risk
Risk management review
Production and post-production activities
Your procedure should also be integrated with other processes, such as: 1) design control, 2) post-marketing surveillance, and 3) clinical evaluation. Your procedure must clearly indicate the priority for implementation of risk control options. The best strategy for ensuring risk control priorities are compliant is to copy the wording of the new EU Regulations verbatim. Your process should include performing benefit/risk analysis. You should also define your process for risk management review. Your review process should specify when subsequent reviews will be done and when your risk management report will be updated. Finally, you should identify a post-market surveillance plan for each device, or device family, and use that post-market surveillance data as feedback in the risk management process.
The one element that appears to be weakly addressed in the body of the standard is the requirement for traceability of each hazard to the other elements of the risk management process. Although traceability is mentioned in Clause 3.5 of the 2nd edition, and Clause 4.5 of draft 3rd edition of ISO 14971, that is the only place is mentioned in the body of the standard. Traceability is mentioned several more times in Annex A, but the focus seems to be on the risk management file. Companies need more guidance on how to achieve this traceability. The appropriate place for this guidance is probably in ISO/TR 24971, but in order to maintain this documentation it is likely that a software database will be critical to maintaining traceability as changes are made during design iterations and after commercialization. This type of software tool is also need to expedite the review of risk management documentation during complaint investigation.
Which Risk Analysis Tool should you use?
In Annex G of ISO 14971:2007, and the EN 2012 version, there are five different risk analysis tools described. The word “described” is emphasized, because informative annexes are not “recommended.” The committee that created the 2nd edition of ISO 14971 wanted to provide several suggestions for possible risk analysis tools to consider. However, each tool has strengths and weaknesses. Additionally, the widespread use of the failure-mode-and-effects analysis (FMEA) tool in the automotive and aerospace industries has spread to the medical device industry and companies seem to believe that regulators prefer the FMEA tool. This is not true. Companies should be trained in all of these tools, training should consist of more than just reading Annex G and the tools should be used where they are most beneficial. My personal recommendations are below:
Preliminary Hazard Analysis (PHA) – This process is absolutely critical during development of design inputs. It is also the most underutilized analysis tool. I have not seen a single example of this tool written in a procedure by any medical device company. I believe this process should be continuously updated as part of training new design team members and should be both product and project specific.
Fault-tree Analysis (FTA) – This process is a top-down approach to risk analysis. It is heavily utilized by transportation engineers when intersections are designed, and accidents are investigated. This tool depicts risk analysis pictorial as a tree of fault modes representing each possible root cause for failure. At each level of the tree, fault mode combinations are described with logical operators (i.e., AND, OR). The information displays frequency of each fault mode quantitatively. Therefore, when you are investigating a complaint, the tree can be used to help identify possible fault modes that may have been the root cause of device failure. You may also be interested in the standard specific to Fault tree analysis (FTA): IEC 61025:2006.
Failure Mode and Effects Analysis (FMEA) – This process is a bottom-up approach to risk analysis. It is heavily utilized by the automotive and aerospace industries. This tool systematically lists all failure modes in groups organized by component. Risks are estimated based upon severity of effect, probability of occurrence and detectability. Over time, the FMEA process split into three tools: 1) process FMEA (pFMEA), 2) design FMEA (dFMEA), and 3) use FMEA (uFMEA). The first is ideal for analyzing and reducing risks associated with manufacturing of devices. In particular, the detectability factor can be linked closely with process validation. The second evolved from the realization that detection of a risk after the device is in the user’s hands does not actually reduce risk. A risk reduction only occurs if detectability is proactive. Therefore, this was stated in Annex G.4 and companies began to eliminate detectability and continued to use FMEA as their primary tool. Due to the widespread familiarity with the FMEA tool, usability FMEAs became popular for documenting risks associated with use of a device. Unfortunately, the only real advantages of a dFMEA and uFMEA are familiarity with the tool. You may also be interested in the standard specific to FMEA: IEC 60812:2018.
Hazard and Operability Study (HAZOP) – In addition to the risks of using devices, there are also risks associated with the production of devices. Processes related to coating, cleaning and sterilization are all processes that typically involve hazardous chemicals. The chemical and pharmaceutical industries use HAZAP as a tool to analyze these process risk and prevent injuries. You may also be interested in the standard specific to HAZOP: IEC 61882:2016.
Hazard Analysis and Critical Control Point (HACCP) – This process is primarily used by the food industry to prevent the spread of contaminated food supplies. Even though it is not typically used by medical device manufacturers, it should be considered as a tool for managing the supply chain for devices. This model is useful when manufacturing is outsourced, or secondary processing is conducted at second and third-party suppliers. Since many FDA inspectors started in the food industry as inspectors, this is also a method that is supported by the FDA as a risk control process for outsourced processes.
How to document your risks?
For simple devices, risk management documentation is a burdensome task. For complex devices, a spreadsheet could include hundreds of lines or more than even one thousand individual lines. In addition, the requirement for traceability requires additional columns in a table. Therefore, it becomes nearly impossible for you to include all the required information on a page that is 11 inches wide. If you expand your page to 17 inches wide, the size of your font will need to be very small. If you make a change, your spreadsheet can be difficult to update quickly. You could purchase a 43” widescreen TV for your monitor, or you can use dual monitors for your display, but changes remain difficult to implement without a mistake.
You need to stop relying upon spreadsheets. Use a database, and don’t use Microsoft Access. Purchase a database that is designed to document design controls and risk management traceability. If your company has software expertise, develop your own software tool to do this. You should also design standardized templates for exporting your reports. By doing this, it will only take minutes to create an updated report when you make design changes. If you describe the risk management activities as notes in your software, the description of these activities can also be automatically converted into summary pages for each report summarizing that risk management activity. You can even prompt the user to answer questions in the software to populate a templated document. For example, you can prompt users to input subsequent updates of your risk management reviews and that can be automatically converted into a summary paragraph. This reporting capability is especially helpful when responding to FDA review questions asking for cybersecurity risks.
Additional Training Resources for ISO 14971
The risk management training webinar was being completely rewritten to address changes proposed in the new draft of ISO 14971 (i.e., ISO/DIS 14971) released in July 2018 and European requirements for compliance with Regulation (EU) 2017/745. The webinar was live on October 19, 2018; but it was recorded for anyone that was unable to participate in the live session.
SYS-010, Medical Device Academy’s Risk Management Procedure, is compliant with EN ISO 14971:2012. The procedure includes templates for documentation of design risk management and process risk management. However, we are rewriting the procedure for compliance with ISO/DIS 14971:2018 and Regulation (EU) 2017/745. The new version of the procedure will be available on or before October 26, 2018. The procedure is temporarily available at a discounted pre-order price, but the cost will increase to $299 once the new version is available.