Qmswrapper Medical Device Quality Software
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by qmsWrapperbased in CANADA
For achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. qmsWrapper is a quality workflow process based system that not only fosters a team-based approach to compliance but introduces an innovative approach to managing QMS, called Managing Through Quality or MTQ - more effective and efficient ...
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by qmsWrapperbased in CANADA
It all starts with your Quality Manual and qmsWrapper. If you are developing medical device, know that MedTec is high-regulated industry, and the FDA and EMA (European Medicine Agency) take compliance very seriously. Whether you’re aiming for CE mark or FDA 510(k) clearance, a Quality Manual is required. But where to start? ...
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