• Medical Device Due Diligence Checklist

    Use this checklist to review a medical device’s documentation, safety, quality, performance, and supplier readiness before approval or deployment.

  • Device Overview

  • Device category or type*
  • Device status in organization*

  • Regulatory and Documentation Review

  • Regulatory status of the device in relevant markets*
  • Available documents*

  • Safety, Risk, and Performance Assessment

  • Risk level*
  • Performance validation evidence available*
  • Biocompatibility, sterility, or interface safety considerations relevant
  • Cybersecurity or data protection concern level*

  • Quality, Supplier, and Operational Readiness

  • Supplier quality management evidence*
  • Manufacturing controls or traceability status*
  • Maintenance and service support availability*
  • Expected implementation or deployment timeline
     - -
    2 digit month, 2 digit day, 4 digit year
  • Reviewer final recommendation*
  • Should be Empty:
Select theme: