In this FDA eCopy webinar you will learn the tips for preparing, printing and shipping your own FDA eCopy submission of a 510k, pre-submission request, De Novo application, etc.
When is this FDA eCopy webinar?
This webinar was recorded on Thursday, November 10, 2016 at 9:00am EST. It’s free to register as long as you ask a question. As new questions are submitted I will create blogs to answer your questions and add the questions to our 510k FAQs page.
Contents of FDA eCopy webinar
The webinar consists registration. Registrants will receive a link to download a recording of the webinar and the native slide deck. You will also receive a copy of my FDA eCopy print and ship template. Additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.
- Redacted FOIA 510k Webinar – $79
- 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.