Unique Device Identifier(Udi) Implementation

Dev R.

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This webinar on Unique Device Identifier (UDI) requirements will discuss the new rules implemented by FDA. Attendees will get an overview of the new requirement and how to implement.

Course Objective:

The US FDA has published the final regulations for Unique Device Identification (UDI). Manufacturers must start implementation planning.

UDI implementation requires understanding of several major steps:

  • Producing compliant device labels, packaging
  • Uploading the appropriate information into the GUIDID
  • Updating affected work instructions and/or standard operating

The UDI regulations include changes:

  • Part 803 (Medical Device Reporting)
  • Part 806 (Medical Devices; Reports of Corrections and Removals)
  • Part 814 (Pre market Approval of Medical Devices)
  • Part 820 (Quality System Regulation)
  • Part 821 (Medical Device Tracking Requirements)
  • Part 822 (Post market Surveillance)

You will learn the UDI elements, where it should be placed (on device, label, labeling and package, and configurations), and the Global Unique Device Identification Database (GUDID) data requirements.

Course Outline:

  • Introduction to UDI requirements
  • Device Classifications
  • Overview of GUDID key concepts (Review of GUDID Modules)
  • The UDI Record
  • UDI on Labels, Labeling and Packaging
  • Submission and 21 CFR 11 requirements

Target Audience:

This webinar will benefit the professionals working in medical device industries.

  • Regulatory Specialists/Managers
  • Labeling specialists
  • Quality Specialists/Managers
  • Quality engineers
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Dev R.,

Dev, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to be coming a consultant in 1982 he worked at GE healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen &Hamilton as Risk Management consultant for nuclear and mass transportation industry.

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