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.
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.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Executive Summary Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Executive Summary Webinar $79
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of 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 the 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 certifications. From 2009 to 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 at 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.