ISO 13485 Medical Devices

ISO is providing free access to medical device manufacturers

Because of the global pandemic, the ISO is providing free access to Covid-19 related standards.  This is something that doesn’t happen every day.  The International Organization of Standardization  is giving an opportunity to view various standards that are applicable to the medical and medical device industries.  The following is a list of what is available…

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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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ISO is providing free access to medical device manufacturers

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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