GOST R 59768-2021 - Std. & Spec

Scope: This standard establishes approaches to organizing the collection, analysis and evaluation (evaluation) of post-production information, including information on the maintenance processes of medical devices where necessary, conclusions and practical recommendations for organizing the collection and analysis of production and post-production information. The standard is intended to assist manufacturers and other users in the practical implementation of the requirements of GOST ISO 14971 in the field of developing, documenting and maintaining a system for collecting and assessing information about the medical device or similar products in question at the post-production stage of its life cycle. Risk management does not end with the release of the finished medical device, so the manufacturer must monitor production and post-production information that may influence its determination of risks and, therefore, risk management decisions.

GOST R 59768-2021 history

2021 GOST R 59768-2021 Medical devices. Risk management. Post-production risk assessment of life cycle of products