🔥 Find me at MedicalDevicesGroup.net 🔥
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
About CE Submissions
The video, slides, and transcript from our CE Submissions webinar are now available at http://medgroup.biz/New-CE-Marking-Rules
See http://medgroup.biz/10x-schedule for details about their 3-hour workshop.
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?
Data integrity & the effect on the medical device industry
ISO 14971 under systematic review
Best way to connect with new market entrants?
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’
MedWatch 3500A form for reporting question
In time for America’s Thanksgiving, for which medical devices are you most thankful? http://bit.ly/thanks-devices
Make it a great week.
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.
Stephen Olson CMC
Marked as spam