Risk management continues to be a hot topic in the medical device world as regulators place additional emphasis on the role of risk management throughout your device lifecycle. ISO 13485:2016 increased expectations for manufacturers to implement risk management throughout their QMS, while ISO 14971:2019 structured and formalized the methods of applying risk throughout the product life cycle.
The FDA is currently in the process of revising 21 CFR 820 to align with ISO 13485, and risk management is sure to be much more prominent in the new revision. Where does all this leave small manufacturers or start-ups that are not experts in risk management activities? This guide is your introduction to implementing risk management with practical examples and with minimal technical jargon. This guide focuses primarily on risk from the design controls perspective, but can be applied to your entire QMS with some minor tweaks.