ISO 14971:2019 new requirements for doing better Risk Management for medical devices

ISO 14971:2019 new requirements for doing better Risk Management for medical devices
ISO 14971:2019 dictates new requirements for doing better Risk Management for medical devices. ISO 14971 provides a generic risk-management framework through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks.