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:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID Guidance, e.g., convenience kits, Class II Implants
• Lessons learned in setting up a FDA GUDID account and maintaining a record
• Live Questions and Answers

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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Discussions

Outsourcing vs Insourcing
http://bit.ly/out-v-insource

Design verification and sample size
http://bit.ly/design-ver

Clinical Evidence for Customized Procedure Packs
http://bit.ly/clinical-ev

Exempt devices requirements in USA
http://bit.ly/exempt-dev

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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

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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

Umesh Uday
Business Head- Sales at Healthware Pvt Ptd
I would like to enroll for the Webnair. Will register for the slot.