Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium

12 Steps for Accurate Medical Device UDI Submissions to the FDA GUDID

Gary Saner UDI Reed Technology

Video, slides, and transcript immediately available!

UDI regulations kick in for implantable, life-supporting and life-sustaining (I/LS/LS) devices, including stand-alone software (and the direct marking of these devices, for certain intended uses) in 2015.

Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:

• 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 and implants
• Notes in setting up a FDA GUDID account

RELEVANT FOR:
• 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

>> Forward this link to colleagues who would value this content.

logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.