Press Release

Premarket Submissions of Device Software Functions

March 31, 2022

Victoria BC (March 31, 2022) StarFish Medical Senior QA/RA Specialist, Helen Simons, provides an analysis of how the November 4th, 2021, FDA draft guidance changes current medical device requirements in the new StarFish whitepaper Premarket Submissions of Device Software Functions.

The publication offers a comprehensive analysis of several areas, including:

  • Background
  • Changes from Previous Version of this Guidance
  • Determination of Risk compared to Previous Guidance
  • Assessment of Risk compared to IEC 62304
  • Documentation required by the Guidance
  • Alignment with IEC 62304

Simons concludes, “Care is needed when planning medical device development with software likely to be submitted to the FDA for authorization, to ensure all required activities and documentation are covered. The expectations between the FDA Premarket Submissions of Device Software Functions guidance and IEC 62304 need to be resolved if industry is expected to comply with both.”

About the Author

Author, Helen Simons, is a StarFish Medical Senior QA/RA Specialist. Helen Simons has over 15 years experience in product development. She has worked on a wide range of Medical Device and IVD products, from inhalers and injection devices to phototherapy devices and ventilators. Her experience includes project managing product developments and providing quality and regulatory guidance to both internal teams and clients.


About StarFish Medical

Empowering Medtech Innovation ®
StarFish Medical is a full service Medical Device Design company offering design, development, and manufacturing services based in Toronto and Victoria. We use our Pathfinder™ process to reduce wasted effort and increase success for medical device product definition, technical engineering, and product development. Prototype and volume production are delivered within an ISO 13485 certified Quality Management System and an FDA registered manufacturing and clean room facility.

StarFish Medical media contact:

Mike Camplin
250.388.3537 x210
[email protected]

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