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De-Risking in the MedTech Industry

In medical device, medtech, quality, Quality Management System, risk management, Uncategorized by Alicia CheungLeave a Comment

Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.

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