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Medical Device developers must have Risk Assessment and they need Traceability, too. It helps them prove compliance and deliver quality products that are safe for patient use. Find out why is Risk Control shown through Traceability Matrix in qmsWrapper.
New version 6.0 of qmsWrapper is finally out and brings us 4 major updates: Integration with Jira Software, upgraded Traceability Matrix, New Risk Module, and Process Engine. What are the benefits and why is now a perfect time for subscribing to the best QMS software for medical device startups find out on our white paper.
An innovative and novel approach to quality and compliance can best be expressed as management through quality compliance as opposed to quality management. Management through quality compliance is different because the focus is not on quality as the end game, but rather on quality as the process to achieve compliance. Find out more…
Whether you are freshly minted into the QMS position or the founder of a Medical Device Startup, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start?” Download this checklist.
There is a lot of information on the Web about implementing a QMS for ISO 13485, but not all very helpful. The danger resides in fluff internet info pieces, written for promotional purposes. If you do QMS right, it’s not a burden, not an added layer of management that gets in the way. The following...
Have your team ever struggled to collaborate successfully in real-time or online? Nowadays, working together remotely is a necessity for most teams and companies. Built-in Team Messaging is designed to Support Team Compliance. Check what Team Messaging offers to you.
QmsWrapper includes an Interactive Quality Manual Creator Tool that helps you create your company’s Quality Manual, that is fully integrated with your QMS processes or workflows, all in accordance with ISO 13485:2016 and U.S.QSR (21CFR 820). Read more…
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.
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.
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...