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What has medical device design to do with a thousand year old game?

May 02, 20190 min read

Written by

Eva Kautenburger

Reviewed in line with our Editorial Policy

So, what has medical device design to do with a thousand year old game?

Well, you might have all the pieces ready for your medical device to work but due to increasing burden of regulations it is more and more difficult to document your design.

For example look at the design below. Cut it along the lines and get 7 pieces of information. Think of the 7 pieces as:

risk management,
user requirements,
system requirements,
software requirements,
software design,
tests,
test results.

Now try to re-establish the traceability, meaning to put together a square for the CE certification. If you manage to do that, spell the letters F, D, or A with the same pieces because the FDA might want to see the same information in a slightly different way.

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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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