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.
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.
- 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.