This standard establishes approaches to risk assessment during the design and development of medical devices and is applied in conjunction with the requirements of GOST ISO 13485 and GOST ISO 14971. The requirements of this standard are applicable to all stages of the life cycle of medical devices that are considered in the design and development of medical devices and include stages of risk analysis and assessment
GOST R 59767-2021 history
2021GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices