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Document Management & Control
Document Management & Control with qmsWrapper for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. What qmsWrapper Document Management System includes? How to organize your files? How to securely store and protect your Business Data and Compliance Documentation with qmsWrapper you can find out by downloading our whitepaper.
Project management with qmsWrapper
New product development success depends on efficient and effective project management. It can be a challenge in smaller companies because typically one person is handling multiple products and multiple teams. How to track, manage and organize your projects and your teams, check on our whitepaper.
Traceability Matrix
An essential criterion for FDA and CE Mark success is Traceability of medical device requirements. Technically referred to as a Requirements Traceability Matrix (RTM), it’s central to the development of safe medical devices as, when it’ s done right, it’s the foundation of your FDA Design History File (DHF) and your CE Mark Technical File...