Medical Device Guide & Checklist

The 10 Essentials for Writing a Clear Product Requirements Document

Executive Summary

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. A well-crafted specification document can become a one-stop reference for personnel involved in the design and development process.

It is possible to make a requirements document that is a helpful, easy-to-use tool. Following the tips in this guide can help ensure you incorporate risk assessment, meet design controls requirements, and create a document that will easily stand up to a regulatory inspection. The key takeaway from this tip sheet should be that a little bit of planning and consistency at the beginning of the requirements process will save time and effort in the longer term.

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