Why you should register for the 510k Summary Webinar
In this webinar you will learn exactly how to write a 510k Summary. I will review the guidance from the FDA as well as provide an analysis of multiple 510(k) summaries for a variety of device types. The webinar will use the 510k summary template provided as an outline for the various topics covered during the webinar.
What you will receive for $79
- access to the live webinar
- a recording of the webinar you can replay anytime
- the most recent version of my templates for a 510k Summary and a 510k Statement
- the native slide deck for this webinar
There will be 25-35 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 510k Summary Webinar?
On Thursday, December 8 we will be hosting the 510k Summary Webinar live at 2:00pm EST.
510k Summary Webinar ($79 – 20 spots left)
In this webinar you will learn how to create a 510k summary for your 510k submission and how to decide if you should use a 510k Statement Instead.
- Biocompatibility Testing Webinar – $79
- Benchtop Performance Testing Webinar – $49
- Redacted FOIA 510(k) Webinar – $79
- FDA eCopy Print & Ship Webinar – Free if you submit a question
- 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.