2 min reading time

Unique device identification (UDI) expert, ReedTech’s Gary Saner, has your answer key.

ReedTech has processed more than 100,000 UDI applications for Class III devices and Class II implants, life-sustaining, and life-supporting devices marketed in the U.S.

If you market a Class II device in the U.S., you’ll need to report your Device Identifier by September 24, 2016.

To help, Gary’s noticed a distinct pattern between (a) applications that sail through FDA GUDID and (b) applications that get sent back.

Tune in to the http://medgroup.biz/UDI-mistakes webinar on December 10 (noon, New York time) and Gary will tell you precisely which mistakes to avoid.

Trust me, it’ll save you a lot of time later.

And even if you can’t make the live event, register now and I’ll send you the replay and slides afterward.

Thanks, Gary. That link again: http://medgroup.biz/UDI-mistakes

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About CE Submissions

The video, slides, and transcript from our CE Submissions webinar are now available at http://medgroup.biz/New-CE-Marking-Rules

JUST ANNOUNCED!
Dr. Bassil Akra (who gave this CE submission webinar) joined the 10x faculty and will present with Rob Packard and Marcus Gould in May.

See http://medgroup.biz/10x-schedule for details about their 3-hour workshop.

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Discussions You May Have Missed

UnitedHealth May Quit Obamacare. Your thoughts?

Low cost tunable sound amplification device?

A Wearable Device for Babies

What would be considered a clean room ISO Class 9?
http://bit.ly/I-so-clean

Data integrity & the effect on the medical device industry
http://bit.ly/d-integrity

ISO 14971 under systematic review

Best way to connect with new market entrants?
http://bit.ly/hw-to-find

Unannounced Notified Body audits within your Value Chain

Healthcare Is Broken, Here’s How We’re Going Fix It

Europe’s Medtech Industry vs. the United States’
http://bit.ly/eu-us-medtech

MedWatch 3500A form for reporting question

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In time for America’s Thanksgiving, for which medical devices are you most thankful?

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Rates for the Medical Device Marketing and Sales Program we created for the group go up this week. Register before Friday and save $200. See http://medgroup.biz/MDMS for information.

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Manfred B.
Director Europe at Providence Enterprise HK
MR. M: JOBS —> https://www.linkedin.com/today/post/author/posts#published?trk=mp-reader-h

Stephen Olson CMC
Chief Consultant @ The Wellsprings Fund LLC
Joe, I get all your promos sent to my email, fine, OK. But, I had a query for you regarding Med Devices, and…? Nada. “Group”, by definition, implies “mutual participation” – No? I’ll resend it again, in case of oversight.