In this biocompatibility webinar, you will learn how to prepare your biocompatibility testing section for an FDA 510(k) submission.
Why you should register for the Biocompatibility Webinar
Notified Bodies prefer to receive a summary technical document (STED) describing the biocompatibility testing for a device rather than being forced to review each testing report in depth. In contrast, the US FDA requires that the full test reports be submitted for review. In addition, the FDA now has specific content questions that are asked in the FDA eSTAR template. These questions ask what conditions were used for testing, the rationale for the samples tested, and on what page information can be found within the testing reports. The FDA also provides a guidance document on the application of ISO 10933-1 that explains specific deviations from the ISO 10933-1 standard that the FDA requires.
Notified Bodies require that manufacturers follow the ISO 10993-1 Standard, and they will accept justifications for not conducting certain endpoint testing. The key to writing a STED is to include enough detail that the reviewer is confident that the required testing was performed, the testing methods were correctly executed and the results met the acceptance criteria. In addition, Notified Bodies need more information about the manufacturing processes, potential contaminants, and residues. The FDA focuses more on colorants and test methods.
In this webinar, you will learn exactly what information is required for both types of submissions and how much detail is required in order to avoid requests for additional information.
What you will receive for $79
- access to the live webinar
- a recording of the webinar you can replay anytime
- the most recent version of the STED biocompatibility testing template
- the most recent version of the template for Vol 15 of a 510k Submission
- the native slide deck for this webinar
There will be 25-35 slides during the presentation. The presentation will be 45-50 minutes in duration, and there will be 5-15 minutes of answering questions submitted through the live chat window or via email after the webinar. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
When is the Biocompatibility Webinar?
The webinar will be hosted live on Wednesday, September 27, 2023 @ 10:30 am EDT. The webinar will also be recorded for anyone who is registering for the webinar or purchasing our 510(k) course after that date.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Biocompatibility Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Performance Testing Webinar ($79)
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
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 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.