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Written by Christopher Scholl
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...
Written by Eric Sugalski
In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations,...
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...
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...
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 –...