In this 510k labeling and UDI requirements webinar, you will learn how to prepare section 13 of a 510k submission for medical devices.
Why you should register for the 510k Labeling Webinar
The 510k labeling and UDI requirements for 510k submissions have changed recently. Regulators have a long list of requirements that must be included for medical device submissions and the current approach is to use a risk-based approach.
What you will receive for $49
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar
The presentation has 25 slides and the presentation is 43 minutes in duration. All deliveries of content will be sent by email to confirmed subscribers.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the 510k Labeling and UDI Requirements Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
Device Description Webinar ($49)
In this webinar we will review the requirements for Section 13 of 510k submissions, and explain the process for creating labeling using a risk-based approach. In addition, we will address the UDI bar codes requirements for draft labeling submitted to the FDA.
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.