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Traceability in Medical Device Software Design

Traceability isn’t just for the final review. It’s a daily tool for safer, smarter and compliant SaMD development.

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Traceability isn’t just for the final review. It’s a daily tool for safer, smarter and compliant SaMD development.

In software development, requirements traceability means you can follow every requirement from its source to implementation.

  • Forward and backward.

  • Across design, tests, and risk controls.

For medical devices, that chain is even more critical.

Because a software bug isn’t just a "ticket".

It can be a health risk.

Written by
Olena Motrichuk
Lead Product Owner

Olena Motrichuk is a Product Owner at Matrix One, where she helps shape software that lets medical device companies build safer products faster. She brings hands on experience from Roche and a strong grasp of how regulated teams actually work day to day. Olena holds an MBA from Berlin Professional School (HWR Berlin) and is based in Berlin.

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