GOST R 59921.8-2022 - Std. & Spec

Scope: This International Standard specifies requirements for a quality management system where an organization needs to demonstrate the ability to provide medical devices and related services that meet customer and applicable regulatory requirements. Such organizations may be involved in one or more stages of the life cycle of a medical device, including design and development, manufacturing, storage and distribution, installation and servicing, and design and development or provision of medical device-related services (eg, maintenance). This International Standard may also be used by suppliers or external parties who supply products and quality management system-related services to such organizations.

GOST R 59921.8-2022 history

2022 GOST R 59921.8-2022 Artificial intelligence systems in clinical medicine. Part 8. Guidelines for the application of ГОСТ ISO 13485-2017