UDI Program Implementation
Duration : 75 Minutes
Dev Raheja,
Dev Raheja, 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 Technologi Read more
FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. The goal of the UDI System is to accurately identify medical devices throughout their distribution and use to enhance patient safety. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labellers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID).
Course Objectives:
The UDI relates to adverse event reporting, identifying and analyzing devices in use, making the post market surveillance system more robust both to enhance patient safety and support pre market approvals and clearance. It will help everyone manage device recalls and also support the global distribution change. The key players are FDA which accredits the issuing agencies that issue UDI's, and the labelers to ensure uniqueness of the code. It will modernize device post-market surveillance, and facilitate medical device innovation.
Course Outline:
• Introduction to UDI
• UDI program requirements
• UDI implementation steps
• Three major tasks in implementation
• Key Roles in UDI Implementation
• UDI issuing agencies
• Creating device ID
• Creating production ID
• The UDI Record
• UDI on Labels, Labeling and Packaging
• Role of GUDID
• Submission Options
• Software UDI Requirements
• New UDI challenges
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Senior management
• Entire software engineering staff
• All hardware engineers
• All technical managers
• Test engineering staff
• Regulatory affairs professionals
• Service managers
• Project Managers and engineers
• Quality Assurance staff
• Marketing Managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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