This webinar answers 510k FAQs and you can register for free by just typing your name, email and a question in the form below.
When is this 510k FAQs webinar?
This webinar was recorded live on Friday, October 14, 2016 at Noon, EDT. It’s free to register as long as you ask a question. There were 14 questions originally submitted in advance for the live recording, but as new questions are submitted I will create blogs to answer your questions and add the questions to our 510k FAQs page.
Contents of 510k FAQs webinar
The webinar recording consists of 17 slides answering 14 unique questions about 510(k) submissions submitted during registration. Registrants will receive a link to download a recording of the webinar and additional questions can be asked at any time by sending me an email or scheduling a call on my contact us page.
- Device Description Webinar – $29
- 510k Hardware Software Documentation Webinar – $129
- 510k Project Management – Lessons Learned – $129
- De Novo Application – $129
- 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.