Medical devices. Guidance on the application of ISO 14971 Ingestion-build-95349 Information to be recorded

Information to be recorded

innovation

generator rooms

High-level design decisions and design strategy

Medical devices. Guidance on the application of ISO 14971 Ingestion-build-95349 Information to be recordedPD CEN ISO TR 24971: 2020 Medical devices Application of risk management to medical devices is a key horizontal standard for the medical device market, guiding manufacturers in the development, implementation and maintenance of a risk management process for medical devices. This document PD CEN ISO TR 24971: 2020 is a Published Document and the UK implementation of an international Technical Report that gives guidance on conforming to BS EN ISO 14971: