In this device description webinar series, you will learn how to write a device description for 510k submissions and CE Marking technical files.
Why you should register for the Device Description Webinar
The device description is not just a paragraph explaining what your device is. The device description comprises Section 11 of a 510(k) submission or the first section of a CE Marking Technical File. In the new FDA eSTAR templates, there is also a requirement for a detailed device description. Regulators have a long list of requirements that must be included for a 510(k) submission or a technical file. The wording of this section must include all the requirements or your regulatory submission will be placed on hold.
What you will receive for $29
- a recording of the four webinars you can replay anytime
- the device description template I use
- the native slide decks for the webinar
There will be 28 slides during the presentation. The presentation is 42 minutes in duration. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
When is the Device Description Webinar?
The device description webinar was updated multiple times as submission requirements have changed:
- October 14, 2016
- March 10, 2022
- April 8, 2022
- November 17, 2022
All four recordings are available when you purchase this webinar.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Device Description Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Device Description Webinar ($29)
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.