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Agile Design Reviews: Nightmare or Dream Come True ?

Design reviews are one of the key processes during the design and development process of medical devices.

They are checkpoints to see whether the design process is still on track and moving forward as it’s supposed to. This makes total sense from an organizational point of view but as well, in regulated environments such as medical devices, it is not surprising that these kind of intermediate checks are required.

In general, the requirements for design reviews are:

  • Systematic

  • Planned

  • At appropriate stages

  • Performed by specialists and independent reviewers

  • Documented

About the Author
Ann Vankrunkelsven
RA/QA Manager