Stage 2 Audit – How to Prepare (Part 1 of 2)

This blog teaches you how to prepare for a stage 2 audit on your pathway to ISO 13485 certification, and this blog is part 1 of 2.

Stage 2 Audit

If you are not sure what ISO 13485 is, please consider our 2-part training webinar on the topic. Health Canada requires ISO 13485 certification as a requirement for all Medical Device License Applications, and most companies choose ISO 13485 certification as their method for demonstrating conformity to the requirements of the European Medical Device Regulations (MDR)–instead of a special MDD audit.

To achieve ISO 13485 certification, you must successfully complete a Stage 1 and Stage 2 certification audit with your chosen certification body. If you are interested in an overview of this certification process, you can download Medical Device Academy’s white paper on this topic, or you can watch a webinar we recorded recently on 6 steps to ISO 13485 Certification.

Management Processes are covered during the Stage 1 and Stage 2 audit

The Stage 1 audit is typically a one-day audit where the auditor is evaluating your readiness for the Stage 2 audit. The auditor will review your Quality Manual, and your procedures (19 are required) to ensure compliance with ISO 13485. Also, the auditor will sample records from critical processes to assess your readiness for the Stage 2 audit. Typically, these processes will be:

Management Review
CAPA
Internal Auditing

After you complete the Stage 1 audit, you may have a few nonconformities identified by the auditor. Responding to these nonconformities is the first step in preparing for your Stage 2 certification audit. You need to initiate a CAPA for each of the auditor’s findings and begin implementation before the Stage 2 audit. Typically, you will have about six weeks to implement these actions. This is not usually enough time to complete your CAPAs because you need more time before you can verify the effectiveness of corrective actions.

Preparing CAPA Records is critical for your Stage 2 audit

In preparation for your Stage 2 audit, prepare for the auditor to review any CAPAs that you completed since the Stage 1 audit–especially if you have evidence of completing an effectiveness check. You may think this is unnecessary because the auditor previously reviewed CAPAs during Stage 1. However, you probably received a nonconformity related to your CAPA process (almost everyone does), and you should expect auditors to review your CAPA process during every audit.

Each CAPA record you present should be provided in a separate folder as a paper, hardcopy. The paper, hardcopy makes it easier for the auditor to review. The folder should include documentation of the investigation, a concise statement of the root cause, and copies of records for all corrections and corrective actions implemented. Corrective actions include procedure revisions and training records. If there is a quantitative measurement of effectiveness, include a graph of current progress with the record. Ideally, the graph will be one of your quality objectives. The graph to the right is an example.

Production Process Controls will get the auditor out of the conference room

Every company has at least some production and process controls implemented before the Stage 2 certification audit. Most auditors and inspectors spend too much time in conference rooms reviewing paperwork and too little time interviewing people that are performing work. However, many companies also outsource production activities. Therefore, unless you have a software product, you can expect your auditor to review incoming inspection activities. The auditor is also likely to review the finished device inspection, storage, and distribution. If the auditor is thorough, they will also follow the trail from inspection activities to calibration activities, nonconforming materials, and data analysis.

Design Controls

If your company is a contract manufacturer, then you probably are excluding design controls (ISO 13485, Section 7.3) from the scope of your Quality System. However, if you are a manufacturer that performs design and development, then it is an element of the quality system that warrants special attention. During the Stage 1 certification audit, the auditor reviewed only your Design Control procedure. During Stage 2, the auditor will look for evidence of implementing design controls. Therefore, even if your company has not completed your first design project, the auditor will still want to see some evidence of implementation. The auditor will expect at least one design plan to be written, and at least one design review should be completed.

If you are familiar with the FDA Quality System Inspection Technique (QSIT) process for inspection, you might have noticed that this blog is divided into the same subsections identified in the QSIT Manual.

Stage 2 Audit – How to Prepare (Part 1 of 2) Read More »

Mar 9 2014

How to Prepare for an FDA Medical Device Inspection

This free one-hour webinar provides a basic overview of how to prepare for an FDA medical device inspection.

FDA Inspection Webinar Topics include:

FDA’s approach to conducting inspections
How FDA prioritizes their inspections
QSIT approach-7 major and minor sub systems
Types of FDA inspections
Management review, internal audits, supplier audits – Which documents FDA may request
“Back room” preparations for organizing the inspection
FDA 483s – Wording, Most common 483s in 2013

Includes Native Slide Deck for FDA Inspection Webinar
* Please note-first 5 minutes-audio only

FSMA How to Prepare for an FDA Medical Device Inspection

FIND OUT EVEN MORE WITH OUR NEW WEBINAR ON DEMAND – 21 CFR 820 – A Roadmap To FDA Compliance

This 90+minute webinar recording, 21 CFR 820-A Roadmap to FDA Compliance, is a must have “insider’s guide” of tips, examples and advice for specific areas where FDA inspectors will focus their inspection efforts related to the 31 sections of the 21 CFR Part 820 Quality System regulation. Click Here For More Information

About Your Instructor

Rob Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering and Strategy. He can be reached via phone 802.258.1881 or email.

You can also follow him on Google+, LinkedIn or Twitter.

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How to Prepare for an FDA Medical Device Inspection Read More »

Jan 29 2014

Are Your Suppliers Qualified? Webinar

Are your suppliers qualified? Webinar for $129:

Are Your Suppliers Qualified? Live Webinar June 25, 2020 @ 11 am EDT

This webinar is intended to teach personnel involved in your supply chain how to qualify new suppliers. A link to download the recording is delivered via AWeber in an email. This webinar will be updated on June 25, 2020. The updated webinar will also automatically come with a new Supplier Questionnaire (FRM-004).

Price: $129.00

Exam and Training Certificate available for $49:

exam5 150x150 Are Your Suppliers Qualified? Webinar

EXAM - Are your Suppliers Qualified

This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.

Price: $49.00

Ancient Supplier Qualification Tools

Auditors and inspectors will ask you, “Are your suppliers qualified?” This is a horrible question. Would anyone answer this question with a “No.” Every manufacturer in the healthcare industry is required to document a process for making sure suppliers are qualified and the ongoing evaluation of those suppliers. Unfortunately, many companies are using the same ancient tools that were developed 50 years ago, and they expend a lot of resources with zero value from their efforts.

Supplier qualification and evaluation should not be a necessary evil for the sake of regulatory compliance. These activities should be strategic. The supplier quality activities should be cross-functional and be a source of competitive advantage for manufacturers. How are your suppliers qualified? Is the right audit question to ask? Auditors always claim to “add value.” How many supplier audits actually do this?

There are no specific rules and regulations on how supplier qualification and evaluation are done. The only requirement is that your company shall have a procedure, do it, and keep records. If you really want a gold star, your process should be risk-based.

There are dozens of popular tools that are recycled throughout this industry—such as the all-mighty “Supplier Survey” and the requirement for ISO Certification. Don’t recycle these tools. Develop your own tools that are specific to your company’s needs. As a starting point, we provide our new supplier questionnaire template (FRM-004).

Are Your Suppliers Qualified? Prove It-Webinar Recording covers:

How to Qualify a Supplier
How to Build Effective Supplier Surveys
Best Practices in Supplier Evaluation
Allocation of Supplier Quality Personnel
Prioritizing Supplier Audits
Qualifying Suppliers without an ISO Certificate

Who should attend?

Senior management,
Supplier Quality,
Purchasing, and
Quality Assurance.

Other Resources

You may also be interested in our procedure for Supplier Quality Management (SYS-011). That procedure includes the following documents:

Supplier Quality Management (SYS-011)
Approved Supplier List (LST-003)
Supplier Evaluation Report Template (TMP-002)
Supplier-Internal Audit Report Template (TMP-003)
New Supplier Approval Request Form (FRM-005)
Supplier Nonconformity Report Form (FRM-006)
Supplier Quality Agreement (FRM-037)
Supplier Nonconformity Report (SNCR) Register (LST-004)

VIEW OUR PROCEDURES – CLICK HERE OR IMAGE BELOW:

About Your Instructor

Rob Packard is a regulatory consultant with 30 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone at 802.258.1881 or email. You can also follow him on Google+, LinkedIn, or Twitter.

Are Your Suppliers Qualified? Webinar Read More »

Nov 2 2013

Medical Device CE Mark: Is ISO 9001 Certification Required?

CE Marking / By Robert Packard / CE Marking for medical devices, ISO 9001, ISO 9001 certification, medical device CE mark: is ISO 9001 certification required?

For the medical device CE mark: is ISO 9001 certification required? The advantages and dangers of focusing too much on ISO certification are also reviewed.

ISO 9001 is a general quality management system standard, and ISO 9001:2008 is the most recent revision. The focus of that ISO 9001 is customer satisfaction and continual improvement. For medical devices, the applicable international Standard is ISO 13485:2003. This Standard is based upon the ISO 9001 standard, but clauses were added for the specific needs of medical device regulations. Also, the focus of the Standard was changed:

For CE Marking of medical devices, there is a European National version of the Standard: EN ISO 13485:2012 (http://bit.ly/ENISO13485-2012). This is the official harmonized version of the Standard, and certification to EN ISO 13485 presumes compliance with the applicable European New Approach Directives (http://bit.ly/PlenaryVoteBlog). It is not, however, “required” to be ISO certified to either Standard for CE Marking.

If a company chooses not to be certified to a harmonized standard, then the company must:

Be audited to one of the New Approach Directives by their Notified Body, and
Demonstrate how the quality management system they have created complies with the requirements of the applicable Directive(s).

Advantages of ISO certification

The primary advantage of ISO Certification is that your quality system is standardized. Standardization makes it easier for auditors to do their job, and for companies to implement “off-the-shelf” solutions for routine issues that most medical device companies are faced with. Your customers will recognize international standards, and this increases consumer confidence. It has been a considerable benefit to the European Union (EU), because the EU Member States (http://bit.ly/CECountries) have been able to rely heavily upon international standards, instead of having legal debates over nuances between technical Standards developed by each member state.

Another advantage of using harmonized ISO standards is that regulators can establish minimum requirements for all companies. In my experience, the ISO standards are more burdensome for low-risk devices than is probably necessary. However, the ISO standards are often less burdensome for high-risk devices than is perhaps necessary. For the CE Marking process to work effectively, manufacturers must be the experts for their specific device and know when it is required to do more than the minimum. For example, there is an ASTM test specification for cyclic testing of orthopedic implants. Still, recent experience with metal-on-metal (MoM) implants has demonstrated that the ASTM test method is not an adequate predictor of long-term safety and performance. If manufacturers do not develop this expertise, then technical reviews for CE Marking can be quite painful and drawn out as the reviewer is forced to educate the manufacturer on the “State of the Art.”

Dangers of focusing too much upon ISO certification

I find that most medical device company managers are well aware of the ISO 13485 requirements today, but I also believe that many are less aware of the requirements of 21 CFR 820 (http://bit.ly/21CFR820-25) than they were before ISO 13485:2003. Some consulting clients have managers that believe certain regulatory requirements are “just an ISO thing.” It concerns me when the Top Management of a company doesn’t understand basic differences between ISO certification, compliance with 21 CFR 820, and other regulatory requirements. It is the responsibility of the Management Representative to promote awareness of regulatory requirements throughout the organization (i.e., ISO 13485, Clause 5.5.1c). Still, the Management Representative needs the support and commitment of Top Management to promote awareness effectively.

CAPAs, Internal Audits, and Management Reviews are core processes of the ISO 13485 standard. Still, these are also regulatory requirements for the US FDA, Health Canada and CE Marking medical devices in Europe. ISO 13485 Certification, however, is only a mandatory requirement for Canadian Medical Device Licensing (http://bit.ly/FindCMDR). Companies need to focus on the core processes of the quality system and get these right first. In many ways, I would prefer to see companies develop their quality system architecture that best fits their needs. One company I audited did this. Their company has “Leadership Principles.” You can map all of the clauses of ISO 13485 to a specific “Leadership Principle” at that company, but there are requirements included in their principles that exceed the requirements of ISO 13485. If there were no ISO standards, we might see more creative thinking and innovation in the area of quality management systems. Therefore, I encourage every Management Representative to challenge the status quo and to think of ways to improve beyond ISO standards AND meet regulatory requirements.

Medical Device CE Mark: Is ISO 9001 Certification Required? Read More »

Oct 21 2013

Quality Management System Training Presentations and Exams

3 Comments / ISO Certification / By Robert Packard / medical device QMS, medical device QMS training, medical device quality management systems, medical device quality management systems training, QMS training, Quality Management Systems

Methods for developing a quality management system training presentation and exam to demonstrate training effectiveness for QMS procedures.

Quality Management System Training

Training records are a basic expectation for any quality system (i.e., Clause 6.2.2 of ISO 13485), but demonstrating effectiveness (Sub-Clause 6.2.2c) and competency (Sub-Clause 6.2.2a) is also required. Verifying training competency will be the subject of a future blog, but this blog focuses on the most common method for demonstrating training effectiveness—an exam.

Resource Needs

The challenge with creating a training exam is that it takes a serious time commitment to create a training presentation, to write an exam, to grade the exam each time an employee is trained, and issue training certificates. Each time you revise the procedure, you need to decide if retraining is required and how you will verify the effectiveness of training on the revised procedure. Finally, you need qualified trainers with appropriate documentation of their competency.

The larger your company is, the more value you will realize from creating training exams. Unfortunately, larger companies usually have more procedures too. It typically takes me 2-4 hours to develop a new training presentation for a process or procedure. I am currently developing training presentations for a small drug/device company that will have approximately 30 procedures. Therefore, it could take 60-80 hours to create training presentations for all the procedures.

Quality Management System Training Presentation Content

We have developed training courses for critical processes, such as CAPA, internal auditing, and design controls. Medical Device Academy will also be offering a free webinar in November on the topic of conducting more effective Management Review meetings. For other processes, such as calibration, we recommend the following step-by-step approach:

Overview slide of requirements
A slide for each sub-clause
An example of how the procedure is applied
An overview of the procedures’ key points

Our calibration procedure required a total of 11 slides—including a title slide and a slide for contact information. We also included a cross-reference to the applicable section of the procedure for each sub-clause of the ISO 13485 Standard (i.e., 7.6a, 7.6b, etc.). A balance used to weigh components was the training example, and there was a slide that explained essential considerations that can affect the accuracy of a balance.

During the process of creating the training presentation, we noticed that one of the sub-clauses of ISO 13485, 7.6, was not addressed by the procedure. Therefore, our systematic approach simplified the creation of a training presentation, and the strategy helped to identify a non-conformity in the procedure before it was released.

Exam Content

Verifying effective training is easiest with the use of quizzes or exams to test what the person learned. For training exams, we try to ensure that exam questions are objective and easy to grade. Therefore, most exams are ten questions. Questions are typically the fill-in-the-blank type of questions or multiple-choice questions. “Trick questions” are not recommended, but we do recommend using questions that force the trainee to look up the answers. This will force the trainee to become more familiar with the procedure.

For our calibration training exam, we could easily have one question corresponding to each slide, but not every sub-clause requirement is equally important. Therefore, we always try to include a question related to the most common things auditors and FDA inspectors will be looking for.

The calibration process includes a requirement to assess the impact on a product if a measurement device used for inspections is found to be Out-Of-Tolerance (OOT). Is there a need to retest or even recall products?

Almost every auditor I meet asks the above question during an audit, and most will even request records of calibrated devices that were found OOT.

Grading & Certificates

We typically use 70% as the criteria for passing an exam. The exams are protected forms with spaces to fill in and checkboxes. There are also spaces for the trainee’s name, title, and date of the training. Exams are emailed to the instructor, and the instructor will unprotect the document. The correct answers are indicated by highlighting the choice in green. Incorrect answers are indicated by highlighting the choice in red. Explanations for why an answer is incorrect are added after the question and highlighted in yellow. The graded exam is then emailed back to the trainee—along with a training certificate similar to the one shown at the beginning of this blog.

Retraining

In one of our blog posts, we recommended including a section on training and retraining requirements in each procedure. The challenge with revised procedures is that retraining is not always required. If retraining is needed, we recommend the following approach:

Create a separate retraining exam
Include a question(s) specific to the procedural revisions
Include a question(s) specific to recent nonconformities in the process (if any)

If you are interested in learning more about procedures, records, and training as it relates to ISO 13485 Certification, please consider our ISO 13485 webinar training.

Quality Management System Training Presentations and Exams Read More »

Oct 2 2013

What is the IEC 60601 Scope?

19 Comments / IEC 60601 / By Robert Packard / IEC, IEC 60601, IEC 60601-1:2025

This blog explains the IEC 60601 scope to help you determine if and how IEC 60601-1 applies to your medical electrical equipment.

The first question to ask about IEC 60601 Scope

One of the first questions clients ask before a project starts is, “Does this medical electrical product fall under IEC 60601-1?” Another common question clients ask is whether IEC 60601-1 applies to battery-operated medical devices. To answer these questions, we must review and understand the scope (sub-clause 1.1) of IEC 60601-1 to determine if and how the IEC 60601-1 Standard applies to a medical electrical product.

The title of IEC 60601-1:2005 (3^rd edition) is Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The IEC 60601-1 Standard itself states, “This…Standard applies to…MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS…referred to as ME EQUIPMENT and ME SYSTEMS.”

*Note: ALL CAPITAL LETTERS identifies a defined term for the IEC 60601 series of standards within this blog. “IEC” is an acronym for the International Electrotechnical Commission. IEC is a non-profit, non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic, and related technologies.

All clause references in this blog are to both IEC 60601-1:2005 (3^rd edition) and IEC 60601-1:2005 (3^rd edition) + Amendment 1:2012, or the consolidated version IEC 60601-1:2012 (edition 3.1), but the actual text comes from edition 3.1.

Definitions

The ME EQUIPMENT definition (sub-clause 3.63) is:

“…equipment…

a) provided with not more than one connection to a particular SUPPLY MAINS, and

b) intended by its MANUFACTURER to be used:

1) in the diagnosis, treatment or monitoring of a PATIENT; or

2) for compensation or alleviation of disease, injury, or disability.”

and “…having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT….”

Note: The above definition aligns well with the description of medical electrical devices in the European Medical Device Regulation.

From the definition above, we know that a device can have up to one power cord, or be hard-wired to the building’s power by one power line, and/or be battery powered.

We also need to understand the term APPLIED PARTS (sub-clause 3.8): “Part of…ME EQUIPMENT…in NORMAL USE necessarily comes into physical contact with the PATIENT for…” the device “…to perform its function.” Classification of the different types of APPLIED PARTS and other classifications (there are eight different classification criteria in the IEC 60601 Standard) need to be completed early in the process of setting up a test plan for design verification to determine the applicable testing requirements, and to develop an appropriate test plan.

Examples within Scope of IEC 60601-1:2005

Examples of electrical medical products fitting the definition above are broad and include battery-operated thermometers, gamma imaging systems, endoscopic cameras, and infusion pumps. IEC 60601-1 may also apply to many ACCESSORIES (sub-clause 3.3) used with ME EQUIPMENT.

Examples not within Scope of IEC 60601-1:2005

The scope of IEC 60601-1 also identifies which devices are not included in the IEC 60601 series:

“in vitro-diagnostic equipment…IEC 61010 series;
implantable parts of active implantable(s) … ISO 14708 series…;
medical gas pipeline systems…ISO 7396-1…”

IEC 60601 & ISO 13485

Design verification must confirm that design outputs (i.e., – product specifications) meet design inputs (e.g., – product must meet IEC 60601-1 requirements).

Many projects don’t identify all the applicable IEC 60601 standards. This could cause multiple nonconformances during an audit by the national regulatory body (i.e., FDA, EU Notified Body), or that you don’t obtain approval to sell and distribute your device from the national regulatory body.

A test plan, with multiple test protocols, is developed from the product specification. This test plan should identify all the requirements of the IEC 60601 series of standards, in addition to any other applicable standards and regulations that apply to the device before performing device testing.

Third-Party Testing

IEC testing can be performed by a third-party test house (i.e., – a safety certification agency, such as a BV, UL, CSA, TÜV SÜD), an independent test lab (i.e., Medical Equipment Compliance Association), or the manufacturer can conduct the testing if they have the proper equipment, trained personnel and a good understanding (i.e., – used the Standard on several projects, and successfully tested previous similar electrical medical device(s) by a third-party test lab, and been approved by a national regulatory body) of the Standard (s). However, for OSHA compliance in the USA, IEC testing should be performed by an Nationally Recognized Testing Laboratory (NRTL).

Design verification reports generated from the test process are either the applicable IEC 60601, and IEC 80601 series of standards test report forms or the manufacturer’s generated test reports.

The Author

Leo Eisner 2024 What is the IEC 60601 Scope? If your company needs help with IEC 60601-1 gap analysis, preparation of the risk management file for the third edition, or training on the Standard, please contact Leo Eisner (the “60601 Guy”). Leo also created a training webinar series on IEC 60601-1, 3^rd edition.

What is the IEC 60601 Scope? Read More »

Sep 18 2013

Risk Classification Process for Health Canada Device Licensing

2 Comments / Health Canada / By Robert Packard

Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents.

Last week, I was visiting a client who was told that their device is a higher risk device classification (i.e., – Class IV) in Canada than it is in Europe (i.e., – Class IIa). Although Canada has its own device classification rules, there are many similarities with European Classifications for CE Marking. A few months ago, I posted a gap analysis (http://bit.ly/gapanalysiscmda) comparing the classification rules in the current MDD (http://bit.ly/M5MDD) to the new classification rules in the proposed European Device Regulations (http://bit.ly/EUProposal). Now, let’s review the Canadian classification rules versus the current European classification rules.

Overview of the European and Canadian Medical Device Classification Rules

There are four European and Canadian medical device classifications. Class I, IIa, IIb, and III are the European classifications, while Class I, II, III, and IV are the Canadian classifications. The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations (http://bit.ly/FindCMDR).

There are 16 risk-based classification rules, with a similar format and organization to the 18 risk-based classification rules in the MDD. Just a glance at the table above reveals that the classification rules for Europe and Canada are similar. However, a closer comparison between the two regulations shows that Rules 1-14 in the CMDR match-up with part or all of a corresponding European classification. Only rules 15 and 16 do not have a corresponding European classification rule.

How to Write a Classification Rationale for Health Canada

Two weeks ago, I wrote a blog (http://bit.ly/riskclass) on how to write a classification rationale for CE Marking of Medical Devices. That blog made use of the European guidance document for the classification of medical devices (http://bit.ly/EUClassification). For Canadian Medical Device License Applications, there is a different guidance document (http://bit.ly/CMDRClassificationGuidance). However, if you already have a European device classification, I recommend the following strategy:

Identify the equivalent classification rule in the CMDR
Write a classification rationale using the rule you identified in the CMDR
Send your classification rationale to the Canadian Medical Device Licensing Division for verification (http://bit.ly/CanadianMDL)

If you have any trouble with step 1, you might try doing a keyword search of an electronic version. For example, the word “gases” in rule 2 of Annex IX in the MDD only appears once in the CMDR classification rules—in rule 5. An alternate approach to identifying the classification is to search Health Canada’s MDALL (http://bit.ly/CanadianMDALL) medical device licensing database for a competitor’s equivalent product. If you don’t know the name of competitor products, you can also use Health Canada’s keyword index (http://bit.ly/CanadianKeywordIndex).

Get Health Canada’s Input

Once you have written your classification rationale, then you should email the classification rationale to Health Canada’s licensing division (http://bit.ly/CanadianMDL). Help with identifying the proper device classification in the CMDR does not require paying a consultant thousands of dollars, because Health Canada will not charge you for this service, and they typically respond within 7-10 days. Their response will confirm you have identified the correct classification for your product, or you will receive an explanation of why another rule is a better choice.

Regulatory Pathway Identification

Medical Device Academy offers a standardized service for identifying the regulatory pathway for device submissions to the United States, Europe, and Canada. We recommend that companies prepare a regulatory pathway document during the initial design planning stage (ISO 13485, Clause 7.3.1) because the harmonized standards identified will become your design inputs (ISO 13485, Clause 7.3.2). The Canadian pathway is always the easiest and least expensive of the three markets mentioned.

Do Not Ask Your CMDCAS Registrar

Your company’s ISO 13485 registrar should NOT attempt to participate in the above classification process. Health Canada specifically tells all CMDCAS (http://bit.ly/CMDCAS) auditors to instruct companies to contact Health Canada directly. The CMDCAS auditor is only supposed to verify that the company has a documented licensing process and documented classification rationale. Health Canada’s Device Licensing Division assesses the accuracy of the rationale.

You may also be interested in joining the LinkedIn Group I manage on this topic (i.e.,- CMDCAS): http://bit.ly/CMDCASLinkedInGroup.

Please join us on Social Media

Risk Classification Process for Health Canada Device Licensing Read More »

Sep 10 2013

CE Marking Routes to Regulatory Approval

3 Comments / CE Marking / By Robert Packard / CE marking

The author reviews the conformity assessment process contained in Annexes VII, II, V, and III related to a company seeking CE Marking regulatory approval.

CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier)—regardless of the device classification. However, the classification of the device has a significant impact on the regulatory approval pathways available to your company. Therefore, the first step in the process of CE Marking of medical devices is to determine the risk classification (http://bit.ly/riskclass). There are four device classifications: Class I, IIa, IIb, and III.

Once your company has determined the risk classification of the device, then you must determine which conformity assessment procedure you will follow to receive CE Marking approval. The conformity assessment procedures available for each classification are identified in Article 11 of the Medical Device Directive (http://bit.ly/M5MDD), and additional detail is provided in the various Annexes (i.e., – Annex II, III, IV, V, VI, and VII). The following table below summarizes the options for each classification:

If your product is a Class I device that is non-sterile and non-measuring, then you will not require a Notified Body (NB). However, all other products will require your company to select a NB (http://bit.ly/SelectingRegistrar).

Annex VII – Declaration of Conformity

If your company does not require NB involvement, then you will be able to issue a Declaration of Conformity In accordance with Annex VII. You will also need to register your product with one of the Competent Authorities (CA) in Europe. CAs are the U.S. FDA equivalent in each EU member state. The following is a list of contact information for all the CAs: http://bit.ly/ContactPoints. If your company does not have a physical presence in Europe, you will also need to select a European Authorized Representative (AR). My recommendation is to select an AR that is one of the 15 members of the European Association of Authorized Representatives (http://bit.ly/EAARMembers).

Annex II – Full Quality Assurance

Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity and also reviews your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls and that your process for establishing and maintaining a Technical File is adequate. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the Certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.

Annex V – Production Quality Assurance

The Annex V conformity assessment process is the most common route to CE Marking for companies that outsource product design to a third-party. If your company outsources design, Clause 7.3 is excluded from your ISO 13485 Certification, and you cannot demonstrate “Full Quality Assurance.” Therefore, the NB will issue an Annex V certificate for “Production Quality Assurance.” Annex IV and Annex VI are alternate conformity assessment procedures, but these are used less frequently for medical devices and are outside the scope of this blog.

Annex III – Type Examination

The Annex III conformity assessment process is a type of examination that is performed for higher risk devices where the company does not have an Annex II certificate. This type of examination involves a review of your company’s design dossier, and the NB issues a Type Examination CE Certificate. This Certificate cannot be used alone for CE Marking. Type Examination Certificates must be used in conjunction with another CE Certificate, such as the Annex V certification for Production Quality Assurance. This combination would be used for Class IIb and Class III devices in place of an Annex II CE Certificate.

If your company needs help with CE Marking, including training on the medical device directive, please contact Medical Device Academy at rob@13485cert.com. We are also developing a webinar series for this purpose. If you interested in more services, try viewing the following blog category page: http://bit.ly/CEMarking.

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Sep 9 2013

Certification Body Selection

4 Comments / ISO Certification / By Robert Packard

The author reviews the certification body selection process for ISO 13485 certification, MDSAP Certification, and CE Marking.

What is a Certification Body?

A certification body is a third-party company that is accredited by an organization like the ANSI-ASQ National Accreditation Board (ANAB) or Standards Council of Canada (SCC) to perform certification audits against ISO Standards, such as ISO 9001 or ISO 13485. Accreditation bodies verify the conformity of certification audits to the ISO/IEC 17021 Standard. Some certification bodies are not accredited or may be self-accredited. Still, you will need a certification body that is accredited to meet the regulatory requirements of Health Canada and European Competent Authorities.

Certification body selection for your company is a critical step on the journey toward ISO 13485 certification. When I first joined one of my previous companies, I was assigned the task of implementing ISO 13485 to comply with the Canadian Medical Device Regulations (CMDR) under the Medical Device Single Audit Program (MDSAP). First, I discovered that the company already had two certification bodies. The company initially received an ISO 9001 certificate from one certification body, and then a few years later, an ISO 13485 certificate was issued by another certification body. Unfortunately, neither certification body was recognized by Health Canada. Therefore, when I joined the company, and we were seeking a Canadian Medical Device License, we had to find a third certification body. This time, I selected a registrar recognized by Health Canada. Then I was able to transfer our ISO 9001 certificate to the new registrar and eliminate the other two certification bodies.

When conducting certification body selection, you will find that there are different names for the term, depending on the country to which you are seeking your certificate. For some of the biggest markets, they are named as follows:

Europe – notified bodies
Canada – registrars
Japan – registered certification bodies
Australia – conformity assessment bodies

8 Points to Consider When Selecting a Certification Body

Refer to the official Europa page that helps you identify the complete list of “possible” Notified Body candidates based on the product category.
The size and reputation of the notified body can have an impact on your customer’s confidence in your QMS. If they are savvy, they know who the key players are, and who has the more credible reputations in the medical device field. Before transitioning to BSI, I experienced “eye-rolling” during customer audits when asked for the name of our notified body.
Consider the level of risk associated with the classification of the medical devices that are currently marketed and those that may be planned for future distribution. The EU Commission and Competent Authorities (US FDA equivalent in European member states) throughout Europe are currently re-evaluating all the Notified Bodies to determine if they will continue to be allowed to issue CE Design Examination Certificates (Annex II.4) and CE Type Examination Certificates (Annex III) for the highest risk devices (i.e., – Class IIb and Class III).
Identify all your regulatory needs unless you want to contract multiple certification bodies (not recommended). Certification bodies are not created equal, and some may not be qualified to provide all the services needed. A certification body qualified to issue a certificate for ISO 13485 may not be able to provide a CE certificate for CE Marking required by the EU, and only 15 certification bodies are recognized by Health Canada as MDSAP Auditing Organizations. To avoid the need for additional certification bodies in the future, you need to identify your long-term certification requirements for the international markets you will be distributed in.
Compare price quotes from each certification body you are considering and make sure that you provide the same criteria to each potential certification body to ensure that you are getting a fair quote. This is also the time to determine ALL costs associated with audits, certificates, and any other fees. Be sure to include any travel costs, as they are part of the fees that will be included in the contract. If you have multiple sites, consider the benefit of utilizing the same auditor for each site for consistency. However, using one auditor can also incur higher travel costs.
Evaluate each certification body’s customer service before the initial certification audits by asking for “360-degree” evaluations by everyone in your organization that will interact with the certification body directly. This includes planners scheduling the certification audits, the accounts receivable department handling invoices for the certification body, and your sales team that may be able to represent a customer’s opinion of the various certification bodies you are considering. Responsiveness is one of the best criteria to evaluate this customer service against. If the certification body is difficult to work with before certification, it won’t get better.
What is your regulatory strategy? Are you looking for a certification body that will conduct an audit that barely meets requirements? Or maybe you want a certification body that will work with you as a partner to build a QMS made up of best practices. I recommend a “picky” certification body. This will ensure that you choose a partner that forces you to improve your QMS and remain competitive with other medical device companies that have embraced the principles of an ISO QMS.
Finally, if your medical devices or the manufacturing process is complex or innovative, you should select a certification body with auditors that have the technical expertise to understand your product and processes. For example, if your company makes special plastic implants that require “gas plasma,” or vapor-hydrogen peroxide sterilization, you want to ensure that the certification body has auditors that understand this sterilization process.

Strategic Decision-Making

For certification body selection, a spreadsheet may help keep track of information. However, the best practice for making this type of strategic supplier decision is a “Proposal A3 Report”. This special type of A3 Report is explained in Dan Matthew’s workbook. Rob Packard, the founder of the Medical Device Academy, used this approach for the certification body selection of a new Notified Body to transfer to for a recent client.

If you need assistance with ISO 13485 Certification or are interested in training on medical device regulations for the United States, Europe, or Canada, please email the Medical Device Academy at rob@13485cert.com, or contact Rob Packard by phone @ +1.802.258.1881.

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Sep 5 2013

How to write a CE Classification Rationale

Leave a Comment / CE Marking / By Robert Packard / CE marking, Medical Device

This article explains how to write a CE classification rationale for medical devices compliant with Annex VIII of the EU MDR.

Note: Blog page is under construction

CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier). One of the requirements of this technical documentation is to establish the risk class of a device in accordance with the classification rules in Annex IX. The requirement to include this classification rationale in the Technical File is not well defined in Article 9, Classification, of the Medical Device Directive (http://bit.ly/M5MDD), but the guidance document for Technical Documentation (http://bit.ly/NBMED251Rec5) clearly defines this requirement in Section 3.2 (viii). Establishing a classification rationale is the first step to establishing the regulatory pathway that will be required to CE Mark your medical device.

What are the CE Marking device classifications?

There are four different classifications of medical devices in Europe: Class I, Class IIa, Class IIb and Class III. These four classifications are also referred to as “risk class.” The lowest risk classification is Class I, and the highest risk classification is Class III. Class IIa is considered a “medium risk,” while Class IIb is considered a “high risk” medical device. Notified Body involvement and a CE Certificate from the Notified Body is required for almost all medical devices distributed in Europe, however, Class I devices that are non-sterile and do not perform a measurement function do not require Notified Body involvement. Class I devices that are sterile are often referred to as “Class I-S,”but this is not a term used in the Directive. The same is true of “Class I-M” for Class I devices with a measurement function.

Applying the classification rules for medical device CE Marking

In order to apply the classification rules as defined in Annex VIII of the MDR, the following questions must be answered for the device or device family:

Is the device invasive? – Invasiveness of a device is an important criterion, because non-invasive devices are generally Class I, and there is typically no Notified Body involvement required for these devices.
Is the device surgically invasive, or invasive with respect to body orifices? If a device is surgically invasive with respect to a body orifice, Rule 5 is the most likely classification rule. For all other devices that are surgically invasive, the duration of use is important
How long is the device used inside the body? The primary difference between Rules 6, 7 and 8 is the duration of use. In general, permanent implants are subject to Rule 8, and are Class IIb devices. The other surgically invasive devices are generally Class IIa devices. Devices under Rule 6 are for “transient” use (i.e., – intended for continuous use for less than 60 minutes). Devices under Rule 7 are for “short-term” use (i.e., – intended for continuous use for between 60 minutes and 30 days.). There are multiple exceptions to each rule, and these exceptions should all be considered.
Is the device electrically powered (i.e., – an active device)? Active devices are subject to rules 9, 10, 11 and 12.
Do any of the “Special Rules” apply? It is recommended to actually start with Rules 13-18 to ensure that one of the special rules do not apply. For example, if you are making blood bags, there is no need to read anything in Annex VIII except Rule 18.

Guidance Document for Classification

Annex IX defines the classification rules for Europe, but there is also a guidance document (http://bit.ly/EUClassification) published that helps to explain the classification rules with examples. This guidance document is extremely important, because it provides clarification of rules based upon interpretations that have been made by Competent Authorities with Notified Bodies and companies. For example, critical anatomical locations are defined in Section 3.1.3: “For the purposes of the Directive 93/42/EEC, ‘central circulatory system’ means the following vessels:…”.

When you write a classification rationale for your technical documentation, it is important to reference this document—as well as Annex IX of the MDD. Your rationale should address each of the questions above for applying the classification rules. In addition, your rationale should indicate that none of the “Special Rules” (Rules 13-18) are applicable to your device or device family.

Mixed Classifications

It is possible to have a device family, contained within one Technical File or Design Dossier, that has more than one Classification. For example, you could choose to group a family of vascular grafts together in one Technical File that are permanent implants and non-absorbable. Normally, these devices would be Class IIb in accordance with Rule 8. However, if one or more of the grafts is intended for vessels included in the central circulatory system, then these grafts would be Class III devices. If a graft can be used for either indication, then the higher classification should be applied.

EU MDR – Regulation (EU) 2017/745

On September 26, 2012, the European Commission released a draft proposal for a new medical device regulation. The expected implementation transition period for these proposed regulations is 2015-2017. In Annex II of the proposed regulations (http://bit.ly/EUProposal), it specifies that the risk class and applicable classification rationale shall be documented in the technical documentation. This appears as item 1.1e) under the heading of “Device description and specification.”

The MDD defines the classification rules for medical devices in Annex IX, while in the proposed EU regulations classification, rules are now in Annex VIII. The MDD also has 18 rules, while the proposed regulations have 21 rules. In order to download a Gap Analysis of the Classification Rules for CE Marking, please visit the following page on this website: http://bit.ly/gapanalysiscmda.

If you need assistance with medical device CE Marking, or you are interested in training on CE Marking, please contact Medical Device Academy at: rob@13485cert.com. Medical Device Academy is developing a webinar series specifically for this purpose. You can also call Rob Packard by phone @ 802.258.1881. For other blogs on the topic of “CE Marking,”please view the following blog category page: http://robertpackard.wpengine.com/category/ce-marking/

How to write a CE Classification Rationale Read More »

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