🔥 Find me at MedicalDevicesGroup.net 🔥
2 min reading time
Long-time readers won’t be surprised that 13485-expert Robert Packard’s workshop at the 10x Conference was standing room only.
Or that he offered to teach his class for free.
Register at http://medgroup.biz/510k-tips for Rob’s free workshop on how to prepare a submission.
Rob says the US FDA 510(k) process changed tremendously in the past two years, and medical device manufacturers need to update their documents and procedures. Two points he made during the workshop generated a lot of questions:
• Make sure you review 100% of the available 510(k) predicates, instead of stopping with the first one that seems to fit. You might even want to create a comparison chart as part of your regulatory pathway analysis.
• If a potential predicate device has a 510(k) statement instead of a 510(k) summary, request a copy of the 510(k) immediately because companies have only 30 days to provide a copy.
If you have anything to do with product development or the 510(k) submission process, you’ll want to attend this live event on Thursday, June 4 at noon, New York time. The recording, slides, and transcript will be available for all who register, whether you attend or not.
That link again: http://medgroup.biz/510k-tips and sign up today because it will be one of our better attended events.
Have a question about 510(k)s? Leave it in the comments and Rob will address it during the live webinar.
THANK YOU to group members like Rob who have shared their knowledge with the group for free.
For marketers and sales people:
You’ll want to attend next week’s webinar, “How To Increase Market Share Using Medical Claims Data.”
Register at http://medgroup.biz/claims-data – it’s next Tuesday at noon, New York time.
Tax leads to lay-offs, frozen R&D, no raises
Eroding margins and the future of the OEM/supplier relationship
Renew/change in existing 510k device
What’s important to meddev manufacturers for packaging?
3D printing for device parts?
Make it a great week.
Joe will make the recording available on his website after the live event so you can watch it. I will also be sending out follow-up emails to everyone with additional information–such as a PDF of the slide deck.
Jan Bill Henschke
James (Jim) Dent
Susan K Jones
Marked as spam