2 min reading time

If you manufacture Class III medical devices, you’ve got a panic-inducing 71 days to comply with Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) guidelines. Are you ready?

http://medgroup.biz/UDI-goes-in-effect-Sept-24

Medical Devices Group Advisory Board member Gary Saner gave two excellent webinars on the subject and, with time running out, I asked if he’d do an encore performance.

July 31 at noon Eastern Time, Gary will speak and will field your many questions.

The required minutia is complicated so you’re welcome to forward the link to the regulatory, operations, and supply chain folks in your organization.

We also will help Class II manufacturers who must implement UDI compliance to meet original equipment manufacturer (OEM) and customer demands.

The UDI / GUDID Compliance Webinar will focus on the necessary steps for submission to the GUDID, including:
• UDI Compliance Deadlines
• GUDID Submission Methods and Approaches
• GUDID Account Set Up Process
• DUNS numbers
• GUDID Data Attributes
• Approved Issuing Agencies

WHO SHOULD ATTEND:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities

To register (it’s free): http://medgroup.biz/UDI-goes-in-effect-Sept-24

As a bonus, once you register we’ll send you links to the first two webinar replays, the transcripts, and slides.

On behalf of the Medical Devices Group, thank you, Gary.

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LAST WEEK’S ANNOUNCEMENT

In a case of “come for the announcement and stay for the comments,” thanks to everyone who contributed to the post “Get The Hell Out Of My Office.”

If you missed it, see http://bit.ly/Hell-No

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DISCUSSIONS

Different clinical trials to market in different countries?
http://bit.ly/clinical-countries

Should you license or produce your medical device invention?
http://bit.ly/license-or-produce

Needed: Samples of PMS (post marketing surveillance) plans for the group
http://bit.ly/PMS-samples

If a research hospital contracts with a funding agency to test a device, is the manufacturer liable?
http://bit.ly/who-is-liable

How important is ISO 13485 if your company is going to use a repair partner?
http://bit.ly/13485-repairs

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. You stay classy, San Diego. What a great turnout last night. Thank you. To our Denver group, see you July 29 at http://medgroup.biz/Denver-July-29