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. 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 webinar you can replay anytime
- the device description template I use
- the native slide deck for this webinar
There will be 25-30 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 Device Description Webinar?
On Friday, October 14 we will be hosting the Device Description Webinar live at 10:00am EDT.
Device Description Webinar ($29)
In this webinar we will explain why the various details in the device description template are required and how to complete each section. The webinar will be 50-60 minutes in length. You will receive access to the live recording, the native slide deck and a blank template for device descriptions intended for 510k submissions and CE Marking technical files.
- 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.