This Special 510k Submission Webinar explains how your design plan should be different for a Special 510k when compared to a traditional 510k submission.

How would your plan be different for a Special 510k?

When is the Special 510k Submission Webinar by Rob Packard?

This Special 510k submission webinar was presented by Rob Packard on Thursday, March 8, 2018. You can access the recording and native slide deck for free as long as you ask Rob a question in the form below. As new questions are submitted we will create blogs to answer your questions and add the questions to our 510k FAQs page. In order to register for the Special 510k Submission Webinar please fill in and submit the form below. You will receive an email confirmation including instructions on how to view and participate in the webinar via Zoom.

Contents of Special 510k Submission Webinar

Registrants will receive a confirmation email, and then after confirmation, they will receive login information for the live Medical Device Academy webinar by Rob Packard. We will also provide: 1) a link to download a recording of the webinar, and 2) a copy of the native slide deck. Additional questions can be asked at any time by sending me an email or scheduling a call on our contact us page.

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.