Medical Device Guide: The 10 Essentials for Writing a Clear Product Requirements Document

Sifting through medical device safety and performance requirements to create medical device requirements specifications can be an exercise of patience, but with the right preparation and approach, it can be more than just another required piece of paperwork. This comprehensive guide and checklist provides teams with a helpful tool to:

  • Streamline Verification and Validation by proactive automated analysis to achieve complete, testable, and measurable requirements.
  • Enforce consistency of terminology from different stakeholders, suppliers, and standards that encompass human factors, environmental considerations, sterilization, biocompatibility, cybersecurity, and much more.
  • Generate a paper trail for Quality Management Systems that demonstrate the project’s hardware and software integration is accountable to the standards necessary for compliance.


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