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Design Freeze is a significant milestone in MedTech. It's the point when you're ready to start the Verification & Validation (V&V) process. It implies maturity of your technical design and also your d...
Written by Christopher Scholl
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Ever built the wrong medtech device?
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I’ve worked at a number of medical device companies and each one took a different approach to writing User Needs and Design I...
Written by Eric Sugalski
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In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations, quality managers primar...
Written by Eric Sugalski
In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between design, quality, and regula...
Picture this -- you've raced to the airport and found yourself at the end of a massive security line. You do the truffle shuffle with shoes off, belt off, keys out, laptop out, while the security agen...
Most of the time, quality (as in “quality management”) is only considered after a design concept is mature, if not finalized. Design control, document control, risk management – they are considered ch...