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Design Controls and Risk Management

Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this video, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk management fits into that process, as well as discuss the ISO and 21 CFR 820 requirements for each stage of the product life cycle. Keywords: Medical devices, regulatory affairs, regulatory compliance, medical device risk management, quality management, quality management system, risk management, risk management plan, risk management strategy, risk management framework, medical device regulatory affairs, medical device regulation, risk analysis and management, risk assessment matrix, ISO 14971, design control medical devices