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

[@shreethoka2490]

Great video!

[@treythorsen225]

This is a FANTASIC video. It explains the complicated Design Control and Risk Management process in a way that's easy to understand!!!

[@clauderamsey9904]

Hello. At time 25:56 you show that Drawings go in the DMR, this is not quite correct. Work instructions, yes but not component and assembly drawings that drive the creation of the work instructions. Drawings may be in the work instructions but, the WHAT is to be made, is in the DHF. I'm in the middle of an audit at the moment and this was made VERY CLEAR me. DHF -What is to be made. DMR - How to make it. DHR - What was made.