This webinar answers 510k FAQs and you can register for free by just typing your name, email and a question in the form below.
510k Boilerplate Webinar
When is this 510k Boilerplate webinar?
This webinar was recorded live on Tuesday, November 8, 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 510k Boilerplate webinar
The webinar recording explains how to complete three templates for a 510k submission. Specifically, the presentation explains how to complete the following sections:
- Section 3 – Confidentiality Statement
- Section 6 – Truthful & Accuracy Statement
- Section 7 – Class III Summary and Certification
- Section 8 – Financial Certification and Disclosure Statement
In addition to receiving access to the live webinar, you will receive the native slide deck and the three templates for these three sections. Registrants will also 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.