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Risk Management The medical device risk management procedure mainly follows the framework specified by ISO 14971. However, there are specific standards for special areas, e.g., software, usability, and biological evaluation. In some countries, the special requirements also include the review guidelines of special devices. Manufacturers of medical devices can meet corresponding regulatory requirements through establishing a risk management procedure that conforms to ISO 14971 and/or specific standards. Our Services: Establish a risk management procedure Plan the risk management process Identify risks Analyze risks Identify risk control measures Complete risk management files |