How do medical equipment companies really let risk management fall?

How do medical equipment companies really let risk management fall?

Compared with the 2003 version, one of the impressive changes in ISO13485:2016 "Medical Device Quality Management System for Regulatory Requirements" is the strengthening of risk management requirements, not only for the full life cycle of medical device products and services. Management, and clarified the requirements for risk management of the quality management system process, and proposed the appropriate process for applying the risk-based approach to control the quality management system (4.1.2b). Risk identification and management control are also mentioned in the procurement process and external supplier control, software validation, training planning, feedback in...
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