In this biocompatibility webinar, you will learn how to prepare your submission for the FDA or a Notified Body with regard to biocompabitility testing.
Why you should register for the Biocompatibility Webinar
Both the FDA and 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. However, each has very different expectations on how the testing should be done. The FDA has a guidance document for this testing and Notified Bodies stick very closely to the ISO 10993-1 Standard. 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 the 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?
On Thursday, December 1 we will be hosting the Biocompatibility Webinar live at 11:00am EST.
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)
In this webinar you will learn how to create a summary technical document (STED) for biocompatibility testing to include in Section 15 of a 510k submission and for a CE Marking technical file.
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.