The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase. (Based on the MDSAP Companion document / FDA).


  • Simple overview / No paper chaos
  • Easy to sort by specific county requirements
  • The checklist supports well during the implementation
  • Helpful overview during the next MDSAP audit

What you get:

  • Instruction for use
  • Technical Support
  • Customer feedback improved tool