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Come September 24, 2015, all medical device manufacturers of Implants, life-sustaining, and life-supporting devices marketed in the U.S. need to submit unique device identifiers to the FDA.
It’s complex, so please accept this free help from my friends at Reed Tech who have submitted thousands of device records to the FDA. They’ve agreed to do our fifth free webinar on the topic on June 9 at 11:00 a.m., New York time.
Register at http://medgroup.biz/UDI-5
The live event is an hour, but each time we’ve gone over by 30 minutes at least, due to the sheer volume of questions. (We record the sessions and make the slides available to all who register.)
On the agenda:
They will lay out your submission options and explain how to make submissions to the Global Unique Device Identification Database (GUDID) submissions before your compliance date.
This webinar is valuable for those upgrading their system used for Class III submissions and for those setting up a new system for Class II and I submissions.
That link again: http://medgroup.biz/UDI-5 and you’ll also get access to their previous slides on the topic.
Please ask your UDI questions in today’s comment section.
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Exempt devices requirements in USA
In this month’s HMEVoice radio program, we discussed the intersection between the medical device and home medical equipment industries. Give a listen at http://bit.ly/HMEVoice
Make it a great week.
P.S. The slides and video for TUV SUD’s presentation on the Medical Device Single Audit Program is now available at http://medgroup.biz/mdsap
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