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Thursday, January 18, 2018

CIMdata Announces the Formation of a Medical Device PLM Action Group

Group to provide research and guidance on the top PLM issues affecting the medical device and life science equipment industries.

ANN ARBOR, Michigan, 18 January 2018—CIMdata, Inc., the leading global PLM strategic management consulting and research firm, announces the formation of its newest PLM member service—the Medical Device PLM Action Group, an association of medical device companies within CIMdata’s globally recognized PLM Community Program. The group is an industry-specific PLM advocacy group, as well as a defining organization for unfulfilled common interest PLM-related capabilities. Action Group members will participate in regularly scheduled meetings to review and discuss research and other actions to address PLM-related topics of common interest with the goal of ultimately driving PLM best practices and solution provider development.

Additionally, members will drive the prioritization of research and analysis to define current PLM best practices, insights, and lessons-learned for medical device companies in topics such as:

  • The reality of the real-time product record (the “digital twin”) driving concurrent compliance and quality documentation for FDA 21 CFR 11, 820 and ISO 13485, associated data structures, and key PLM areas of interest, e.g., DHF, DHR, and UDI/UPC.
  • The level of risk in maintaining information silos, e.g., best practices and strategy for managing and ultimately integrating PLM with QMS and ERP, including definition of ownership and boundaries of each and limits of the systems.
  • Overcoming the misperception of PLM as a “last step” reporting tool vs. an in-process productivity tool.

Membership is open to medical device and life science equipment manufacturers.

Peter Bilello, President of CIMdata, stated, “CIMdata is excited to announce the formation of a new PLM Action Group based on our extremely successful A&D PLM Action Group framework formed a few years ago. This new group, focused on the medical device industry, will define and direct the research efforts on key PLM areas needed to meet future challenges. Action group member experiences with PLM-related implementations, best practice research, and close examination of emerging technologies will help the group define what the PLM solution providers should offer and/or enhance.”

Participation in the CIMdata-led Medical Device PLM Action Group offers:

  • Access to ongoing research, analyses, insights, and advice important to medical device manufacturers.
  • Participation in the identification of industry-specific PLM topic areas for research.
  • A uniform voice to the PLM Solution Provider community to better enable and guide them in their development efforts.
  • Access to CIMdata’s PLM subject matter experts.
  • An interactive and collaborative environment for accessing and sharing PLM-related processes and best practices.
  • Participation in CIMdata’s global PLM Community.

The Medical Device PLM Action Group is led by James L. Roche, a CIMdata Executive Consultant, who brings extensive industry experience and on-the-ground knowledge to the group. Mr. Roche stated, “As medical devices become more complex, connected and intelligent, and regulatory compliance varies across different global markets, the medical and healthcare device manufacturers must embrace new best-practice strategies and trending technologies. The time has come for joint action by industry leaders to remediate current and emerging pain points that are common across their industry.”

For more information about the Medical Device PLM Action Group see, or contact CIMdata at This email address is being protected from spambots. You need JavaScript enabled to view it. .

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