Why you should register for the Performance Testing Webinar
Both the FDA and Notified Bodies prefer to receive a summary technical document (STED) describing the performance testing for a device rather than being forced to review each testing report in depth. 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 this webinar you will learn exactly what information is required in the STED and how much detail is required in order to avoid requests for additional information.
What you will receive for $49
- a recording of the webinar you can replay anytime
- the most recent version of the STED performance testing template
- the native slide deck for this webinar
There are 29 slides in the presentation. The presentation is 46 minutes in duration–including the Q&A session from the live presentation. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Performance Testing Webinar – $49
In this webinar you will learn how to create a summary technical document (STED) for benchtop performance testing to include in Section 18 of a 510k submission and for a CE Marking technical file.
- 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.