Search Results for: 13485

De Novo Application Webinar – 2024 Update

Leave a Comment / By

In this De Novo Application Webinar you will learn about the latest FDA guidance and how to use the latest FDA eSTAR template.

Your cart is empty

De Novo Application Webinar ($79)

This webinar was hosted live in 2019 and again in 2022. We are updating the De Novo Application webinar to include guidance and requirements for 2024. The webinar explains the process for a De Novo application to the FDA using the latest version of the FDA eSTAR.

Thumbnail for De Novo Application Webinar Updated for 2024 De Novo Application Webinar 2024 Update
De Novo Application Webinar
This webinar is updated for 2024 and we are hosting it live. Rob Packard is hosting the updated De Novo Application webinar on August 1, 2024. The updated webinar explains the process for a De Novo application to the FDA using the latest version of the FDA eSTAR v.5.3.
Price: $79.00

10- Question Exam and Training Certificate available for $49.00:

Training Effectiveness Exam4 300x223 De Novo Application Webinar 2024 Update
Exam - De Novo Application
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

Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.

If you have a device that falls into one of the following categories, your device is generally eligible for the De Novo process:

  • lack of an identifiable predicate device,
  • new intended use, or
  • different technological characteristics that raise different questions of safety and effectiveness.

Devices that are not substantially equivalent solely based upon a lack of performance data are not eligible for the De Novo process.

When is the De Novo Application webinar?

This webinar will be live on Thursday, August 1, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis. 

De Novo Application Webinar Content

  • Updates for FY 2024
  • Our firm’s experience with De Novo applications
  • De Novo Application Guidance Document
  • De Novo With or Without Preceding 510k
  • De Novo Pre-Sub Meetings and Questions to Ask
  • Which sections of the application are unique to a De Novo?

What you will receive in the De Novo application webinar:

  • Recording of live webinar
  • Native PowerPoint Slide Deck

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of the De Novo webinar.

About Your Instructor

Winter in VT 2024 150x150 De Novo Application Webinar 2024 Update

Rob Packard is a regulatory consultant with ~25 years of 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 the 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. 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. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

De Novo Application Webinar – 2024 Update Read More »

MDR Quality Plan – for EU Regulation 2017/745 Compliance

2 Comments / CE Marking / By

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.

Days until MDR Transition 1024x126 MDR Quality Plan for EU Regulation 2017/745 Compliance

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 the 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 the 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. Your 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 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:

  1. Conformity assessment procedure / significant change procedure – SYS-025
  2. Identification of safety and performance requirements (i.e., Essential Requirements Checklist) – FRM-038
  3. Management responsibilities – SYS-003
  4. Resource management, including suppliers – SYS-004 and SYS-011
  5. Risk management – SYS-010
  6. Clinical evaluation – SYS-041
  7. Product realization, including design, production, and service – SYS-008, SYS-012, and SYS-013
  8. UDI requirements – SYS-039
  9. Post-market surveillance – SYS-019
  10. Communication with competent authorities notified bodies and other economic operators – SYS-049 (new requirement)
  11. Vigilance reporting, including serious incidents and field safety corrective actions – SYS-036 and SYS-020
  12. Corrective and preventive actions – SYS-024
  13. Monitoring and measurement of processes – SYS-017

Note: If you are interested in one of the procedures listed above that does not have a hyperlink, please contact me via email at rob@13485cert.com. The procedures are available, and the links will be provided during the 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.

The 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 to meet Annex II of Regulation 2017/745. Fourth, post-market surveillance documentation must be updated 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.

The implementation timeline for MDR quality plan

If any of your devices are being reclassified, you will need to implement all of the above changes before 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 can 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. The best-case scenario could be four (4) years after the transition deadline.

MDR Quality Plan – for EU Regulation 2017/745 Compliance Read More »

EU Regulation Webinar Series – January 24 Start

Leave a Comment / By

This EU Regulation webinar series consists of eight one-hour webinars designed for medical device manufacturers that are CE Marking medical devices.

Your cart is empty

Regulation 2017 745 EU Regulation Webinar Series 1024x341 EU Regulation Webinar Series January 24 Start

This webinar is designed to provide training for medical device manufacturers that are CE Marking or intend to CE Mark products. The training is specific to the new Regulation (EU) 2017/745. Training will be conducted live each week on Thursdays at Noon EST. However, each session will be recorded, and you will receive access to download the recording for training of current and future employees.

How to demonstrate the effectiveness of the EU Regulation Webinar Series

We provide short quizzes to verify that training was effective for each webinar. The webinar series costs only $825/company, and this includes quizzes and training certificates for one person. If you want quizzes and training certificates for additional people, these can be purchased at any time for $49/quiz or $312 for all eight quizzes. These webinars will also be available as individual purchases for $129/each.

EU Regulation Webinar Series Content

  1. January 24, 2019 – Overview of Changes: Introduction, Transition Dates, Economic Operators, Expert Groups, Recertification of NBs, Validity of Certificates, and Transfers for Authorized Representatives and NBs (Annex XII)
  2. January 31, 2019 – Classification & Reclassifications: How to prepare a classification rationale; Annex VIII – Classification Rules; Annex XVI, Devices without a medical purpose
  3. February 7, 2019 – Conformity Assessments: Annex IX, X and XI; Notification of Significant Changes; Post-Certification Scrutiny; Annex XIII – Procedures for Custom-made Devices 
  4. February 14, 2019 – Annex I: Essential Requirements & Labeling Requirements, UDI implementation
  5. October 19, 2018 – Creating a Risk Management File compliant with new MDR
  6. February 21, 2019 – Technical Documentation: Annex II
  7. February 28, 2019 – PMS and Clinical Data: Annex III, Annex XIV, Annex XV, Clinical Investigations, Clinical Evaluations, PMCF, and Post-Market Surveillance
  8. March 7, 2019 – Areas with Significant Changes: Annex IV – EU Declaration of Conformity, Vigilance Reporting, Record Retention, Single-Use Devices & Reprocessing, Annex VI – UDI and other information submitted to economic operators

What you will receive:

  • Invitation to participate in 7 live training webinars (Thursdays @ Noon EST, starting January 24, 2019)…One training session was recorded on October 19, 2018
  • Recording of 8 webinars
  • 8 Native PowerPoint Slide Decks
  • 8 Quizzes for Training Effectiveness
  • 8 Training Certificates for Successful Completion
  • 30-minute, private discussion via Zoom to discuss your MDR quality plan or any matters related to Regulation (EU) 2017/745

Webinar Series is $825.00 (Includes eight webinars, native slide decks, eight quizzes, and certificates for training effectiveness):

Regulation 2017 745 EU Regulation Webinar Series 1 EU Regulation Webinar Series January 24 Start
EU Regulation Webinar Series
This EU Regulation webinar series consists of eight one-hour webinars designed for medical device manufacturers that are CE Marking medical devices. The training series begins on January 24, 2019.
Price: $825.00

Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.

About Your Instructor

Rob 150x150 EU Regulation Webinar Series January 24 Start

Rob Packard is a regulatory consultant with 25+ years 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. 2009-2012, 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. He can be reached via phone at 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, YouTube, or Twitter.

EU Regulation Webinar Series – January 24 Start Read More »

Design Plan Template – with Risk Management

1 Comment / Design Control / By

This article defines the requirements for design and risk management planning that were used to create our new design plan template.

Design Plan Template Graphic 1024x194 Design Plan Template with Risk Management

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 the 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 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

The 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 the commercial release of the device. My recommendation is to have a review at every stage for every project. If your 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 an excellent opportunity to document changes to the design procedure, design plan, and any other adjustments to the documentation that may require the completion of a new version of a form.

The 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–including your risk controls. 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 the user’s needs to this diagram. The challenge with the 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.

The 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 in design controls and risk management. However, training and competency are not equivalent. To demonstrate competency, you must have prior experience documented in that area.

What is required in a Risk Management Plan?

EN ISO 14971:2019 requires a risk management plan in Clause 4.4. In addition, there are 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 analyze 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 nine activities that should be included in your risk management plan:

  1. Hazard identification
  2. Risk estimation
  3. Risk evaluation
  4. Risk control option analysis
  5. Risk control verification of effectiveness
  6. Benefit/Risk analysis
  7. Evaluation of overall residual risk
  8. Risk management review
  9. Production and post-production activities

How to purchase our new Design Plan Template

Medical Device Academy’s new design plan template is an associated form sold with the purchase of either of the following procedures: 1) Design Control Procedure (SYS-008), 2) Risk Management Procedure (SYS-010). You can also learn more about design control requirements by registering for our updated design controls training webinar.

Other Blogs About Design Controls

Medical Device Academy wrote the following blogs on the topic of design controls:

Other Webinars About Design Controls

The following webinars are available on the topic of design controls:

Design Plan Template – with Risk Management Read More »

Purchasing Controls and Supplier Qualification

2 Comments / ISO 13485:2016 / By

This article identifies the requirements for purchasing controls and supplier qualification procedures, as well as best practices for implementation.

Suppler qualification 1024x377 Purchasing Controls and Supplier Qualification

Purchasing Controls

Sourcing suppliers in the medical device industry is not as simple as going on the internet and finding your material and purchasing it. As part of a compliant quality management system, purchasing controls must be in place to ensure that quality products and materials are going into your device and that any service providers that your company uses in the production of your product or within your quality management system are qualified.

ISO 13485 Requirements

In light of that, ISO 13485:2016 sections 7.4.1 Purchasing process, 7.4.2 Purchasing information, and section 7.4.3 Verification of purchased product outline the purchasing controls for medical device manufacturers. The following are requirements for the evaluation and selection of suppliers:

  • The organization must have established criteria for the evaluation and selection of suppliers.
  • The criteria need to evaluate the supplier’s ability to provide a product that meets the requirements.
  • It needs to take into consideration the performance of the supplier.
  • It must consider the criticality and the effect that the purchased product may have on the quality of the medical device.
  • The level of supplier assessment and monitoring should be proportionate to the level of risk associated with the medical device.

Maintaining Purchasing Controls

To start, in the most basic sense, purchasing controls involve procedures that ensure you are only purchasing from suppliers who can meet your specifications and requirements. The best way to keep track of your qualified suppliers is to maintain an Approved Supplier List (ASL). You should only purchase products or services that affect your product or quality management system from companies on the ASL (you would not necessarily need to qualify things like office supplies or legal assistance through purchasing controls).

When used effectively, the Approved Supplier List can be a great tool to manage the key facets of purchasing control and keep track of supplier monitoring. Items that you can capture on the ASL include:

  • Supplier Name
  • Scope of Approved Supplies
  • Contact Information
  • Status of Approval (Approved, Pending, Unapproved, etc.)
  • Qualification Criteria
  • Supplier Certification and expiry dates
  • Monitoring Requirements/Activities
    • Date of Last Review
    • Date of Next Review

The first step in your purchasing procedure should involve checking to see if the supplier is under active approved status on the ASL. The second step will be to ensure that you are purchasing an item/service that is within the scope of approval of that supplier. If you have not approved the supplier, or the intended purchase is beyond the scope of that supplier, your purchaser will need to go through the necessary channels to add the supplier to the ASL or modify their scope on the ASL.

Supplier Qualification Criteria

As required by the FDA, the level of supplier assessment should be proportionate to the level of risk associated with the medical device. The FDA is not prescriptive about the use of specific qualifications or assessments for different types of suppliers, so that is up to your company to determine. This is a somewhat grey area but based on years working with companies and suppliers, as well as participating in FDA and ISO 13485 audits, there are some general expectations of vendor qualifications that we have observed and would recommend.

It is good practice to have a form or template that guides your supplier evaluation process. Using input from engineering and QA to first determine the level of risk and the requirements of that supplier, and then base your qualification plan on that information. If you have a higher risk supplier who may be supplying a critical component to your device, or providing a critical service such as sterilization, then your qualification process will be much more involved.

Here is an example of two different levels of criteria based on the type of supplier (the intent is not for the following items to be rules, and your company is responsible for determining the adequate acceptance criteria for suppliers, but this is a general example of what you may expect).

  • Critical Custom Component Supplier
    • ISO 13485 Certification
    • On-site audit of supplier’s facility
    • References
    • Provides Certificates of Analysis (CoA)
    • A written agreement that the supplier will communicate with the company regarding any changes that could affect their ability to meet requirements and specifications.
    • You validate a production sample, and it meets requirements
  • Non-Critical Consumable Supplier
    • Product available that meets the needs of the company.
    • An associate has previously used by an associate who recommends the supplier.
    • Adequate customer service returns allowed.

Additional Function of Supplier Evaluation Forms

The supplier evaluation form can also be used as the plan to assign responsibility and track completion and results during the initial evaluation. It can also include the plan for ongoing monitoring and control of the supplier. This evaluation form should be maintained as a quality record, and auditors will frequently ask to see supplier evaluations.

Are Supplier Audits Required as Purchasing Controls?

Also valuable, supplier audits may be included as part of an evaluation plan for a new supplier, the change of scope of a supplier, a routine audit as part of ongoing monitoring, or as part of a nonconformity investigation of a high-risk product. While it is not required by ISO 13485, nor does the FDA does specify in the CFR that you must audit suppliers, it is a very good idea to audit your critical suppliers. If an auditor or FDA inspector sees evidence that your current purchasing controls are inadequate, performing supplier audits may be forced as a corrective action.

Beyond that, you can gain so much value, and gather countless clues and important information in an audit that you just cannot get without visiting your critical supplier. You can see where they plan to/are making/cleaning/sterilizing/storing your product. Talk to the people on the line, are they competent and trained? Does the company maintain their facility well? How secure is it? Do they maintain adequate records and traceability? Have there been any nonconformities relating to your product that have been detected? Etc.

Supplier audits should also include evaluation of the procedures, activities, and records of the supplier that could have an impact on the product or service they are providing your company. If it is not the first audit of the company, you should be sure to review the previous audit report findings and ensure the company has addressed any nonconformities, review supplier performance data, information about any changes that may have occurred at the supplier since your last visit, etc.

Record Maintenance and Ongoing Evaluation of Suppliers

No matter the method of supplier qualification, it is best practice to maintain supplier files that contain useful information relative to the supplier that may include:

  • The original supplier qualification form
  • Supplier certificates
  • References
  • Audit reports
  • Subsequent performance evaluations
  • Expanded scope qualifications
  • Supplier communications
  • Current contact information
  • Copies of any non-conforming material reports related to the supplier, etc.

ISO 13485 requires monitoring and re-evaluation of suppliers, and maintaining detailed supplier files will assist in meeting this requirement, and will help in the feedback system to identify and recurring problems or issues with a supplier. On a planned basis, whether that is annually, or every order (dependent on the criticality of the product), your company should conduct a formal supplier evaluation to determine whether the supplier has continued to meet requirements – In general, annual supplier reviews are standard. Additionally, you must specify this frequency in your procedure (auditors will look for what period you specify in your procedure, and then will check your ASL to make sure all of your suppliers have been reviewed within that timeframe).

During the supplier evaluation, if you find there have been issues, you need to determine and weigh the risks associated with staying with that supplier, and document that in the supplier file. If you determine the supplier should no longer be qualified, then you must also indicate on the ASL that the company no longer approves of the supplier.

Making the Purchase

When you have verified your supplier is approved on the ASL, you are authorized to purchase a product. Engineering is usually responsible for identifying the product specifications, requirements for product acceptance, and adequacy of specified purchasing requirements before communication to the supplier. The specifications may be in the form of drawings or written specifications. Additional information communicated to the supplier should also include, as applicable, an agreement between your company and the supplier that the supplier will notify you before the implementation of changes relating to the product that could affect its ability to meet specified purchasing requirements. When the first batch of product is received from a particular supplier, it is a good idea to verify that the product performs as intended before entering into production with new material or components.

Supplier Nonconformity

From time to time, you may encounter issues with a supplier. Sources of nonconformity include incoming inspections, production nonconformities, final inspection, or customer complaints. You must notify your supplier of the nonconformity and record their response and assessment. Depending on the level of criticality of the vendor, it is reasonable to require them to perform a root cause analysis to determine and alleviate the cause of failure. You should also request documentation of an effectiveness check to ensure the supplier has taken corrective actions. You should maintain copies of supplier nonconformity reports in the supplier file, and discuss nonconformities during ongoing supplier evaluations.

If the supplier does not cooperate or fails to address the nonconformity in an acceptable manner, or if there is a pattern of nonconformities with the vendor, then you should disqualify the supplier, and indicate that the supplier is “not approved” on the ASL.

Purchasing Controls Procedures You Might Need

Medical Device Academy developed a Supplier Qualification Procedure, Purchasing Procedure, and associated forms that will meet purchasing controls regulatory requirements for ISO 13485:2016 and 21 CFR 820.50. These procedures will help you ensure that goods and services purchased by your company meet your requirements and specifications. If you have any questions or would like help in developing a custom procedure or work instructions that meet your company’s unique needs, please feel free to email me or schedule a call to discuss.

Purchasing Controls and Supplier Qualification Read More »

Biocompatibility testing questions answered in pre-submission requests

1 Comment / 510(k) / By

This article is a copy of my responses to someone that submitted biocompatibility testing questions in preparation for a 510k pre-submission webinar.

510k pre submission webinar February 22 for LinkedIn.jpg 1024x459 Biocompatibility testing questions answered in pre submission requests

Can you please answer the following questions related to biocompatibility for a 510k pre-submission meeting request?

This was the request by a person that registered for a 510k pre-submission webinar that was recorded in February 2018. The person asked some great questions that are very similar to other clients I work with. They also requested the biocompatibility testing questions in a way that did not divulge any confidential information–other than to indicate they live in Germany. Therefore, I am sharing my email response with you. Please register for this webinar and submit your questions. Questions are entered in an open text box, and you have room to ask multiple questions.

Biocompatibility testing question #1: Does the FDA now already ask for the AET (Analytical evaluation threshold) for chemical analyses?

This is exactly the type of biocompatibility testing questions you should be asking in a 510k pre-submission meeting. If you ask, “What biocompatibility testing is required for a 510k?” You will only receive a reference to the FDA guidance for biocompatibility. A better approach is to ask a biocompatibility testing lab to provide a Biological Evaluation Plan (BEP). Then you can submit your plan as part of the 510k pre-submission meeting request and include this question regarding the section of the BEP where you explain how you intend to perform chemical characterization of your device and how you intend to determine whether the materials represent risks related to sub-acute toxicity and sub-chronic toxicity endpoints.

Biocompatibility testing question #2: How can I avoid time-consuming genotoxicity studies for FDA?

Typically if you perform the “Big 3” (i.e., cytotoxicity, irritation, and sensitization), and then you perform chemical characterization, you are often able to prepare a Biological Evaluation Report to explain why there are no identified compounds in the chemical characterization that would warrant performing the genotoxicity studies. This is also often true for acute toxicity testing and sub-chronic toxicity testing. This often saves > $10K. To verify the FDA will accept this approach, you will typically provide a biological evaluation plan (BEP) as part of your pre-submission request. Your biocompatibility testing questions should specifically reference your BEP.

Question #3: And how can I face FDA with a cytotoxic wound dressing but which passed irritation, sensitization, genotox, and pyrogenicity tests?

I had a product that contained aluminum. Aluminum is cytotoxic to the cell line that is used in the cytotoxicity testing. However, aluminum does not have a high level of toxicity for the route of administration for that product. You should identify the reason why your product is cytotoxic and then explain why the device is no toxic for the intended use and duration of contact. This would normally be part of that BEP mentioned above.

Biocompatibility testing question #4: Which genotoxicity tests are state of the art for the FDA?

There are three ways to determine that. One is to look in the recognized standards database on the FDA website. The second is to review the FDA guidance on biocompatibility and application of ISO 10993-1. Finally, you can ask the FDA about the suitability of another test you want to perform during a pre-sub. If they prefer a different test, they will say so in an email response, and they are available for discussion by conference call during the pre-sub meeting to clarify their response.
I did not answer this question outright, because biocompatibility requirements change over time. This is also true for other verification testing standards. In fact, for one 510k project, I had seven different standards change just before submission. During a pre-submission meeting, the FDA should make you aware of coming changes to these tests. Also, better biocompatibility testing labs are aware of the changes before they are implemented. This is because the lab managers participate in the committees that revise and update international standards.

Will the meeting be recorded since I live in Germany?

Yes, all of my webinars are recorded. You will receive an email with a link for downloading the recording within 24 hours of completing the original live webinar or at the time of purchase if you are purchasing one of our previously recorded webinars. You can also schedule calls with me as a follow-up using the following link: http://calendly.com/13485cert/30min.

Biocompatibility testing questions answered in pre-submission requests Read More »

Risk Management Requirements – 510k vs DHF

1 Comment / 510(k), Design Control, ISO 14971:2019 (Risk Management) / By

What are the differences between 510k risk management requirements and risk management requirements for your Design History File (DHF)?

Risk management requirements integration with design

Last week I presented a free webinar on how to combine risk management with design controls when planning to submit a 510k. Many questions were asking what the design control and risk management requirements are for a 510k.

What are the 510k design control requirements?

There is no specific part of the regulations stating what the 510k design control requirements are. However, some aspects of the DHF are required as 510k design control documentation, but not necessarily in the exact form as maintained in the DHF. For example, Design Inputs and Design Outputs are presented as applicable recognized standards and design specifications, while others will remain precisely the same (i.e., verification and validation test reports).

What are the Risk Management Requirements in a 510k?

For 510k submissions, the only risk management requirements are the inclusion of risk documentation for devices containing software of at least moderate level risk. There are some exceptions to this as well, though, based on a few special control guidance documents—especially when the submission type is an abbreviated 510k. This is article identifies which of the DHF and RMF elements are 510k design control requirements and 510k risk management requirements.

Quality system requirements for design controls

Design Controls are identified in 21 CFR 820.30. Every manufacturer of any Class II or Class III devices and certain Class I devices (Class I devices with software, tracheobronchial suction catheters, surgeon gloves, protective restraints, radionuclide applicators, radionuclide teletherapy devices) need to control design per this regulation. The requirement for a Design History File is item j) and states:

“Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed following the approved design plan and the requirements of this part.”

The “requirements of this part” refer to the other bullets in 21 CFR 820.30 which can be summarized as:

a) Establish and maintain procedures to control the design of a device.

b) Design and Development Planning – Each manufacturer shall establish a plan that describes the design and development activities and defines responsibilities for implementation.

c) Design Inputs – Manufacturers need to ensure design requirements relating to a device are appropriate and address the intended use of the device.

d) Design Outputs – Design outputs need to be documented in terms that allow an adequate evaluation of conformance to design input requirements. Design outputs that are essential for the proper functioning of the device should be identified.

e) Design Review – Formal documented reviews of design results should be planned and conducted at appropriate stages of device development.

f) Design Verification – Design verification confirms that the design output meets the design input requirements.

g) Design Validation – Design validation shall be performed under defined operating conditions on initial production units or their equivalents. It shall ensure that devices conform to defined user needs and meet the intended use of the device.

h) Design Transfer – Design transfer documentation shall ensure that the device design is correctly translated into production specifications.

i) Design Changes – changes should be identified, documented, validated/verified, reviewed, and approved before their implementation.

The Design History File is intended to be a repository of the records required to demonstrate compliance with your design plan and design control procedures. While companies are required to create and maintain this documentation according to the FDA regulation, not all of the documentation will be reviewed as part of the 510k. The following table compares the elements that comprise a DHF with the 510k design control requirements.

DHF Element 510k Design Control Requirements
Design Plan Not Required
User Needs & Design Inputs

Declaration of Conformity

User needs are design requirements that require design validation (e.g., adequacy of user training, and safety/performance of the device for the indications for use). Some design inputs will appear in the form of standards in the FDA eSTAR template. If you are declaring conformity with these standards, a Declaration of Conformity is automatically created in the FDA eSTAR template.
Design Outputs

Device Description (Section 11)

The Device Description lists the specifications of the device, and your Design Outputs document will help populate the Device Description. This can include drawings, pictures, or written specifications that describe your device.
Labeling

Proposed Labeling (Section 13)

The labeling is usually considered part of the Design Outputs within the DHF and is included specifically in the labeling section of the 510(k) submission. This includes both the Instructions for Use and any Package Labeling.
Verification and Validation Protocols

Not Required

You do not have to include the protocols, but the reviewer may ask to see them if they have any questions when reviewing the reports.
Verification and Validation Reports

Sterilization (Section 14)

Biocompatibility (Section 15)

Software (Section 16)

Electrical Safety and EMC (Section 17)

Bench Performance Testing (Section 18)

Animal Performance Testing (Section 19)

Clinical Performance Testing (Section 20)

Of course, not all of these sections will be applicable to every device. Still, you should include all relevant validation test reports within your submission in the appropriate part of the 510k. Typically, each of these sections will have a cover sheet that outlines the reports that are included within the section, and then you can just include the report from the DHF in its entirety behind the cover sheet in that section.
Process Validation Only required for sterilization validation typically, but there are exceptions for novel materials and coatings
Work Instructions Not Required for 510k
Design Review Meeting Minutes Not Required for 510k
Design Trace Matrix Only required for software
Risk Management File Sometimes – See Risk Management File Table Below
Post-Market Surveillance Plan Not Required, but a few exceptions for high-risk devices
Clinical Data Summary Required only if used to demonstrate safety and efficacy
Regulatory Approval It Will result from 510k Clearance, so nothing is to be included in the 510k submission.

510k Risk Management Requirements

Regarding the FDA regulations for risk management, there is a requirement under the Design Validation section of 21 CFR 820.30 that states:

“Design validation shall include software validation and risk analysis, where appropriate.”

For FDA compliance and CE Marking, both recognize ISO 14971 as the standard for risk management. FDA recognizes ISO 14971:2007 whereas EN ISO 14971:2012 is the European National version for CE Marking. Rob Packard wrote an article describing the contents of the risk management file as well as the specific differences in the requirements between the FDA and CE Marking with regard to ISO 14971.

For your 510k submission, the FDA only requires risk management documentation to be included if the product contains software, and the risk is at least a level of “moderate concern”. There are some other cases when risk management is required by special controls guidance documents, but even when it is required, you only have to submit your risk analysis. The table below describes the risk management requirements in greater detail.

RMF Element 510k Risk Management Requirement
Risk Management Plan Not Required
Hazard Identification

510ks with Software Only (Section 16)

Hazard Identification is only required for devices that have a software component. It is not required for most other devices.
Risk Assessment

510(k)s with Software (Section 16)

Certain Special Controls Guidance

The Risk Assessment is only required to be included in your device contains software, or if a special controls guidance document specifically requires a risk assessment. It is not required for other 510ks.
Risk Control Option Analysis Software and Certain Special Controls Guidance
Risk Control Verification and Validation

Sterilization (Section 14)

Biocompatibility (Section 15)

Software (Section 16)

Electrical Safety and EMC (Section 17)

Bench Performance Testing (Section 18)

Animal Performance Testing (Section 19)

Clinical Performance Testing (Section 20)

This will not be any additional or special documentation specific to Risk Management and was already included in the DHF breakdown above. Still, the verification and validation also relate to risk management in ensuring that the risks have been adequately mitigated.
Risk-Benefit Analysis

Not Required for 510(k)

Risk-Benefit analyses are only required for De Novo applications, Humanitarian Device Exemptions, and PMAs.
Informing Users and Patients of the Risks

Labeling (Section 13)

Part of the risk management will appear in the Labeling section of the 510k as warnings, contraindications, and precautions within the Instructions for Use and Package Labeling.
Risk Management Report Not Required

Special Controls Guidance Documents with Risk Management Requirements

Your first step in preparing your 510k submission is to search the FDA Guidance Document Database to determine if there is an applicable guidance document for your device. You can read another blog we wrote to explain Special Controls Guidance documents, and how to determine if one applies to your device. The following list provides examples of Class II Special Controls Guidance documents that require risk analysis to be included within the 510k:

When there are 510k risk management requirements, the special controls guidance document will typically state, “We recommend that the summary report contain:

An identification of the Risk Analysis method(s) used to assess the risk profile in general as well as the specific device’s design and the results of this analysis. (Refer to Section 6 for the risks to health generally associated with the use of this device that the FDA has identified.)

Discussion of the device characteristics that address the risks identified in this class II special controls guidance document, as well as any additional risks identified in your risk analysis.”

The special controls guidance will also identify risks to health that have been identified for products of that type, which you should be sure to include in your risk analysis as appropriate.

More Information on Design Control and Risk Management Requirements

Hopefully, you are now able to determine which elements of your DHF are 510k design control requirements and which elements of your RMF are 510k risk management requirements. If you would like more information about how to implement design controls and risk management within your product development process, please consider registering for one of our training webinars:

If you need any further information or specific assistance with your 510k submission, please feel free to send me an email at mary@fdaecopy.com or schedule a call with our principal consultant, Rob Packard. He can answer any of your medical device regulatory questions.


Click here to schedule a 15 minute call 300x62 Risk Management Requirements 510k vs DHF

Risk Management Requirements – 510k vs DHF Read More »

Canadian Device Licensing Webinar Live on May 24, 2017

Leave a Comment / By

The Canadian Device Licensing Webinar will teach you how to prepare a Class II, III or IV device licensing application for Health Canada–including the new electronic submission process.

Canadian Device Licensing Webinar Canadian Device Licensing Webinar Live on May 24, 2017Why you should register for the Canadian Device Licensing Webinar

Most companies still believe that Europe is the first market to enter for new medical devices. However, the regulatory pathway for Canadian device licensing is generally quicker and less expensive than the pathway for both the USA and Europe–especially for Class II devices. In fact, for a Class II device the entire process is typically completed in 30-45 days and the cost is $385 (CAN). In contrast, registration and listing in the USA is currently $3,382, and the cost of a 510(k) is equivalent to the cost of a Class III Canadian Device License Application (this is expected to change with fee increases in the USA for FY2018). The other advantage of a Canadian submission is that the Technical File content required for a Class III or Class IV submission can easily be repurposed for a European CE Marking submission. In this webinar you will learn:

  1. The different device classifications for Canada
  2. The submission requirements for each class
  3. The new electronic submission requirements for Health Canada’s license applications
  4. How to map an existing Technical File for CE Marking to Health Canada’s requirements

What you will receive for $49

  • a recording of the webinar you can replay anytime (mp4 format)
  • the native slide deck for this webinar (PPT format)

There will be approximately 50 slides during the presentation. The presentation will be approximately 60 minutes in duration, and you will have the opportunity to ask questions during the live webinar. Content will be sent via AWeber emails to confirmed subscribers.

Your cart is empty

Canadian Device Licensing Webinar ($49)

Canadian Device Licensing Webinar 3 150x150 Canadian Device Licensing Webinar Live on May 24, 2017
Canadian Device Licensing Webinar
The Canadian Device Licensing Webinar will teach you how to prepare a Class II, III or IV device licensing application for Health Canada--including the new electronic submission process.
Price: $49.00

When is the Canadian Device Licensing Webinar?

On Wednesday, May 24 we will be hosting the Canadian Device Licensing Webinar live at 2:00pm EDT.

Q&A

Please submit questions to me by email at rob@13485cert.com regarding the Canadian Device Licensing Webinar. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.

About Your Instructor

Vater Headshot 150x150 Canadian Device Licensing Webinar Live on May 24, 2017

Mary Vater is a regulatory consultant with ~7 years experience in the medical device industry. She is a graduate of Wichita State University in Biomedical Engineering. Mary has both quality system and regulatory affairs experience with a variety of medical devices–including 510k submissions and CE Marking. Mary joined Medical Device Academy as a full-time employee in March 2017. She can be reached via phone (913) 274-9899 or email. You can also follow her on LinkedIn.

Canadian Device Licensing Webinar Live on May 24, 2017 Read More »

IFU validation is not a risk reduction – Deviation 7

1 Comment / Clinical Studies & Post-Market Surveillance, Validation / By

This article describes how to perform IFU validation before commercialization and how to conduct post-market surveillance to ensure that your IFU continues to be suitable as your user population and patient population expand.

IFU Validation and PMS IFU validation is not a risk reduction Deviation 7

Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If a regulatory expert creates the IFU, the IFU will be nearly identical to the competitor IFU. However, if a marketing person creates the IFU, the IFU will explain how your product is different from the competitor’s product. Neither approach is practical.

Creating a risk-based IFU

EN ISO 14971:2012 identifies deviations between the ISO 14971:2007 international standard and the three EU Directives. However, deviation #7 is specific to labeling and instructions for use. Even if your product is not CE marked, you should be developing a risk-based approach to IFUs. The priority of risk controls is to eliminate and reduce risks by design, manufacture, and selection of materials. The second priority is to implement protective measures such as alarms to warn users of risks. The last priority for risk controls is to inform users of residual risks. The best practice is to utilize a risk traceability matrix to document each of the risk controls you implemented to eliminate and reduce the risks of hazards identified.

The EN version of ISO 14971 will not allow you to reduce risks quantitatively in your risk assessment for information provided to users about risks, because this type of risk control is not entirely effective. However, you are required to verify that each residual risk is disclosed to users in your IFU, and you must validate that your warnings, precautions, and contraindications are adequately identified such that users understand the residual risks. You are also required to determine any user training needed to ensure specified performance and safe use of your medical device in accordance with ISO 13485:2016, Clause 7.2.1d. Clause 7.2.2d) requires that your company ensure that user training is made available. Any user training you provide should also be validated for effectiveness.

When to perform IFU validation

Some companies ask physicians that helped them with product development review draft IFUs. However, these physicians are already familiar with your product, and your company, and they are highly skilled in the specific procedures your device will be used for. After your experts have made their final edits to your draft IFU, you now need a “fresh set of eyes.” The best approach is to validate the effectiveness of your IFU with potential users that don’t know you or your company. If your product requires animal performance testing or human clinical studies, you could use these studies to validate your IFU. However, I recommend conducting a simulated use study before conducting animal or human studies. Conducting a simulated use study before animal and human studies can prevent deviations from your documented protocols that were caused by the inadequate review of the IFUs.

Methods of IFU validation

The best method for validating your IFU is to perform a simulated use study or human factors study. The FDA published a human factors guidance document that can help you assess the risk of human factors and ergonomics. The FDA guidance requires that you identify your intended user population(s). For each individual population of users, you are required to have a minimum of 15 users for your study. If your product is not for specific indications, you may be able to select 15 users at a few sites randomly. However, if your device is intended for two different specialties, then you need 30 users–15 for each specialization.  I recommend recording a video of simulated use studies too. Videos identify small details that you might miss, and clips from the videos are useful in creating training videos for future users.

Gathering Post-Market Surveillance

Post-market surveillance is not just asking customers if they are satisfied. You need to continue to monitor adverse event databases, your complaint database, and any service records to determine if there are any new risks and to verify that the risks you identified were accurately estimated concerning severity and probability of occurrence of harm. Clinical studies and PMS are the only way you can gather data regarding the likelihood of occurrence of harm. When you design your post-market surveillance questions, make sure you include questions explicitly targeting the residual risks you identify in your IFU. You should also ask, “What indications do you use this device for. Specifically, please identify the intended diagnosis, treatment, and patient populations.” This wording is more effective than asking if a physician is using your product “off label.”

Revalidation of IFU after labeling changes

Changes to labeling and IFUs should always be considered design changes and may require revalidation. If the switch is in response to a complaint or CAPA, then you must revalidate the IFU and labeling to verify the effectiveness of your corrective action. Any validation should be documented, reviewed, and approved before implementation, and acceptance criteria should be determined ahead of time. Your acceptance criteria should be quantitative, so you can objectively determine if the change is valid or not. You might be able to copy your previous IFU validation protocol or simulated use protocol and simply repeat the validation precisely as you did before with new users. However, sometimes the reason why the IFU was not 100% effective in the past is that the risk you are addressing in the revised IFU was not evaluated adequately in the original simulated use protocol.

New webinar for risk-based IFU validation and PMS

If you want to learn more about using a risk-based approach to developing IFUs, validating IFUs, and performing post-market surveillance to monitor the effectiveness of your IFU, then please click on the webinar link below.

IFU Validation Webinar Button 300x62 IFU validation is not a risk reduction Deviation 7

If you are interested in ISO 14971 training, we were conducting a risk management training webinar on October 19, 2018.

IFU validation is not a risk reduction – Deviation 7 Read More »

IFU Validation Webinar – Risk-Based IFUs and PMS

Leave a Comment / By

The IFU Validation Webinar will teach you how to perform IFU validation prior to commercialization and how to conduct post-market surveillance to ensure that your IFU continues to be suitable as your user population and patient population expand.

IFU Validation and PMS 300x163 IFU Validation Webinar Risk Based IFUs and PMSWhy you should register for the IFU Validation Webinar

Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If the IFU is created by a regulatory expert, the IFU will be nearly identical to the competitor IFU. However, if the IFU is created by a marketing person, the IFU will explain how your product is total different from the competitor product. Neither approach is effective. In the current regulatory environment you must use a risk-based approach, perform IFU validation and monitor post-market surveillance to determine if your IFU needs to be changed. In this webinar you will learn:

  1. How to develop your IFU using a risk-based approach
  2. Methods for IFU validation
  3. New Tools for gathering post-market surveillance and PMCF data
  4. How to revise and revalidate your IFU

What you will receive for $49

  • a recording of the webinar you can replay anytime (mp4 format)
  • the most recent version of my template for a Draft IFU (Word doc)
  • the native slide deck for this webinar (PPT format)

There is a 28 slide presentation, and the presentation is 45 minutes in duration. Content is sent via AWeber emails to confirmed subscribers.

Your cart is empty

IFU Validation Webinar ($49)

IFU Validation and PMS 150x150 IFU Validation Webinar Risk Based IFUs and PMS
IFU Validation and PMS Webinar
In this webinar you will learn how to validate your IFU prior to commercialization and how to conduct post-market surveillance (PMS) to ensure that your instructions for use continue to be suitable as your user population and patient population expand.
Price: $49.00

When is the IFU Validation Webinar?

This presentation was recorded live on Friday, April 21, 2017, but you can purchase the native slide deck and the recording anytime.

Q&A

Please submit questions to me by email at rob@13485cert.com regarding the IFU Validation Webinar. If you have company-specific questions, please send me a request to set-up a private call to discuss your specific issues.

About Your Instructor

Rob 150x150 IFU Validation Webinar Risk Based IFUs and PMS

Rob Packard is a regulatory consultant with ~25 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. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.

IFU Validation Webinar – Risk-Based IFUs and PMS Read More »

Scroll to Top