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.
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.
- Performance Performance Testing – $49
- Redacted FOIA 510(k) Webinar – $79
- FDA eCopy Print & Ship Webinar – Free if you submit a question
- FDA Form 3654, Declaration of Conformity – $49
- 510k Boilerplate Webinar – Free if you submit a question
- How to Complete Your 510k Cover Letter – $29
- UDI-Labeling Requirements Webinar – $49
- Device Description Webinar – $29
- 510k FAQs Webinar – Free if you submit a question
- Small Business Qualification Webinar for 510k Submissions – $29
- 510k Hardware Software Documentation Webinar – $129
- 510k Project Management – Lessons Learned – $129
- De Novo Application – $49
- How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% – $129
- FDA Pre-Sub Meetings – $129
- 510k Submissions: Predicate Device Selection – $129
- 510k Submissions: Substantial Equivalence – $129
- 510k Submission Section 4: Indications for Use – $129
- 510k Project Management Webinar – $129
About Your Instructor
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.