Why you should register for the Executive Summary Webinar
In this webinar you will learn exactly how to prepare your Executive Summary in minutes using a template and by copying and pasting content from other sections of your submission. I will review the guidance from the FDA as well as provide information from three other 510k submissions for a variety of device types. The webinar also reviews how to complete each section of an RTA Checklist.
What you will receive for $79
- a recording of the webinar you can replay anytime
- the most recent version of my templates for the Executive Summary and the FDA RTA Checklist
- the native slide deck for this webinar
There are 22 slides in this presentation. The is 33 minutes in duration.
Executive Summary Webinar $79
In this webinar you will learn how to create an Executive Summary for your 510k submission and how complete an RTA Checklist to ensure your 510k Submission is ready.
- 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.