PRD for Medical Devices

Developing Product Requirements for

Medical Devices


By Walt Maclay

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This guide shows you how to write product requirements to provide good V&V evidence for submission.


Download This Guide

Learn how to write product requirements for medical devices that aid in a more rapid approval process. Includes links to templates to help you write:

  • Marketing Requirements Document (MRD)
  • Product Requirements Document (PRD)
  • Software Requirement Specification (SRS)
Our samples will show how to clearly and unambiguously articulate the product’s functionality and behavior while providing solid V&V evidence for FDA approval.

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Walt Mclay
Walt Maclay

About the Author

Walt Maclay is the president and founder of Voler Systems, founded in 1979 and now one of the top electronic design firms in Silicon Valley. Voler Systems is committed to delivering quality electronic products that are easy to manufacture, on time, and on budget.

Voler Systems provides design development, risk assessment, and verification of new devices for medical, consumer, and industrial applications. Voler is particularly experienced in designing wearable and IoT devices, using its skill with sensors and wireless technology.

Mr. Maclay has been active in several consultant organizations and is a senior life member of the Institute of Electrical and Electronic Engineers (IEEE).

He is a reviewer for NSF SBIR grants and has mentored dozens of startup companies. Voler Systems is a member of a technology consortium, the Product Realization Group, which provides all the services to design and introduce new hardware products.

Mr. Maclay holds a BSEE degree in electrical engineering from Syracuse University.