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qmsWrapper

Quality Management System to organize your FDA, ISO and CE submission

qmsWrapper is a smart quality management tool that makes your regulatory life a lot easier. You'll never start another device project without it again. Powerful Document Control, integrated and synchronized with the Project, integrated Risk control, cornerstone to your Life-Cycle processes and DHFs, version control, implemented processes, end to end traceability with the Traceability Matrix. Organize & Plan your FDA (510(k), DeNovo or PMA), ISO 13485,14971 & CE submissions, from start to finish. Streamline your compliance issues and enhance both quality and productivity, try the qmsWrapper way.