Archimedic Blog
The Latest Medtech Insights from Archimedic.
Are you adapting an existing quality system from QSR to QMSR/ISO 13485?
If so, you're not alone, and you may be finding that the transition isn’t completely seamless.
To bring everyone up to speed, ...
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...
Ever built the wrong medtech device? I’ve worked at a number of medical device companies and each one took a different approach to writing User Needs and Design Inputs. And it’s no wonder—FDA CFR and ...
In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations, quality managers primarily focus on identifying and ...
In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between Design, Quality, and Regulatory functions. Questions ...
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...
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