A good understanding of these requirements is required to ensure that your QMS compliance continues. The word risk appears twice as often in this research as in previous versions! Risk and risk management are now clearly defined and a risk-based approach is required to control appropriate processes in QMS. ISO 13485 was revised in 2016 with a heavy emphasis on risk and planning. Developing and deploying a QMS that meets the requirements of this standard is essential for commercializing your medical device in many important global markets. ISO 13485 is the international standard that outlines the requirements of the Quality Management System (QMS) for medical devices.
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