GOST R 59770-2021 - Std. & Spec

Scope: This standard provides guidance on the preparation of a risk management report and its updating, which is a requirement of GOST ISO 14971–2011, section 8. The standard is intended to assist manufacturers and other users of this standard in the practical implementation of the requirements of GOST ISO 14971 in the field of preparing a management report risk and its updating in various cases: during design and development, at subsequent stages of the product life cycle, if there is no information on risk management for previously developed projects

GOST R 59770-2021 history

2021 GOST R 59770-2021 Medical devices. Risk management. Guidelines for the preparation and updating of a risk management report