![]() ![]() What is a risk management report and risk management fileĭr.Personnel and responsibilities in the risk management process.A breakdown of the risk management process.Dieter Dannhorn breaks down the requirements of ISO 14971 compliance and explains how to strategically implement the standard into your quality system. But, implementing ISO 14971 can be intimidating. EN ISO 14971:2012 defines risk management processes for medical device manufacturers. Manufacturers around the world are recertifying to the new standard, which emphasizes risk management as a key component of quality management systems. ![]() Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. ![]()
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