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Lightning Workshop: Solving the UDI Challenge — Putting the Regulatory & Implementation Pieces Together

Jay Crowley  (Vice President, USDM Life Sciences)

Tim Stout  (CEO, Stout Laser Etch LLC)

Faycal Benayad-Cherif Ph.D  (Business Manager Software & Vision, FOBA)

Location: 210D

Date: Thursday, February 13

Time: 9:00 am - 10:30 am

Vault Recording: TBD

To promote global harmonization, the International Medical Device Regulators Forum (IMDRF) set-out basic UDI requirements, including recommended "shared" data elements, in their guidance document titled Unique Device Identification (UDI) of Medical Devices. As the medical device manufacturing community begins to develop and implement country or regulator-specific UDI or UDI-like systems, the new regulatory, commercial, and patient-safety use-cases are creating novel and complex challenges in order to establish and maintain robust global systems and processes. And, the implementation has not been without its challenges. When it comes to marking metal or plastic medical devices, UDI has increased the complexity of laser marking that can affect yield, cost, and potentially result in product recalls.

Topics covered include:

  • Ways the healthcare and medical device manufacturing community can work together to improve safety, effectiveness, and quality while reducing risks and costs
  • Tips and tools for upending the traditional siloed approach to data and information to improve safety and performance
  • Current practices and new laser technology that validates the readability of the UDI marked content before the device transitions to packaging
  • Best practices that help to achieve consistent, accurate, and reliable parts marking on the different materials used by the medical industry