Performance Testing Webinar

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.

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Performance Testing Webinar – $49

tensile testing 250x250 1 150x150 Performance Testing Webinar
Benchtop Performance Testing Webinar

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.

Price: $49.00

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About Your Instructor

Rob 150x150 Performance Testing Webinar

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.

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