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.
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.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Performance Testing 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 – $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.
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.