ISO 13485 Medical Devices

Risk management for medical devices

ISO 14971 for Medical Devices – Application of Risk Management to Medical Devices The factors involved in mitigating risks in the medical device industry are large and complex. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to…

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Medical Devices

ISO/TR 24971:2020 – Medical Devices – guidance on the application of ISO 14971 This document provides guidance on the development, implementation, and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO…

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