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.

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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.

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Discussions:

Tax leads to lay-offs, frozen R&D, no raises
(111 comments)

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?
http://bit.ly/3D-med-parts

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Rob Packard
510(k), CE Marking & Quality System Consultant
Thank you for registering everyone!

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.

Rob Hoveling
Technical Documentation Specialist at AQTIS Medical™, a Sinclair company
Will this be available for watching on a later date? I’m on a holiday, the 4th…

Alan Murray
Technical Manager – Core Imaging Group at Canon Medical Research Europe Limited
I’ve registered.

Jan Bill Henschke
Export Manager at Mini Crosser A/S
Thanks, for a Dane – US rules can sometimes be very strange.

James (Jim) Dent
Manufacturing Validation Enginee at DePuy Synthes Companies
Thanks for the link; I’ve registered.

Susan K Jones
CEO & founder, Nulumina. Chairman, Nanoquantum Sciences. Photonics geek. Wildlife Advocate. Explorer.
Joe, thank you for the link.

Alan Barta
Documentation Specialist at AppleOne Employment Services
Having done so successfully on first try, let me give you the keys. Develop a complaint workplace. Keep excellent design history. Classify your device or pharma, which defines whether you’ll need a clinical trial or not. Benchmark other designs for significant equivalence. Beware of labeling, which include IFUs, packaging, and technical manuals. Cover every area in the CFRs in your submittal. Good luck.