Medical Device Guide & Checklist: 10 Essentials for Clear Requirements

Sifting through medical device safety and performance requirements to create medical device requirements specifications can be an exercise of patience. A well-crafted specification document can become a one-stop reference for personnel involved in the design and development process.

Over the past few years, our team has worked with dozens of systems engineers and business analysts working on ambitious medical device projects to create the ultimate list of tips on how to write product requirements documents that are a dream to author and use. A few things have become abundantly clear to us:

  • The most devastating project errors and delays begin in the requirements authoring stage
  • Agreement on requirements engineering best practices can be a fierce debate

We distilled the insights from our research into this guide + checklist that will help accelerate the requirements engineering phase of your medical device projects.  



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