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Agile Design Reviews: Nightmare or Dream Come True ?

April 02, 20190 min read
Written by
Eva Kautenburger
Reviewed in line with our Editorial Policy

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

Learn more about MatrixReq
Written by
Eva Kautenburger
CCO

Eva Kautenburger is Chief Customer Officer at Matrix One, where she leads Customer Success & Supp across the full portfolio of regulatory and quality management solutions for the medical device industry. A certified I. and II. Party Auditor with deep expertise in ISO 13485, EU MDR/IVDR, IEC 62304, and 21 CFR Part 820, she brings both the technical fluency and regulatory grounding that MedTech customers need to navigate complex compliance landscapes. In her role, Eva oversees a cross-functional team of Solution Consultants, Solution Engineers and Account Managers, driving onboarding, retention, support and strategic growth for customers ranging from emerging device companies to global enterprises as well as consulting intiatives to support customers in their regulatory journey.

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