Archive for August 2020

Risk management

ISO 31000:2018 Risk Management – Guidelines Although not truly a standard, ISO 31000 provides guidelines on risk management analysis within an organization. The application of these guidelines can be customized to any organization and its context. It is a guidance document that provides a common approach to managing any type of risk and is not industry…

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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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G3 Solutions, Inc. can conduct ISO Internal Audits

“How do we conduct our ISO internal audits?” This is one of the many questions that plagues smaller companies with limited resources and makes for interesting discussion.  Many organizations struggle with the resource availability to either conduct internal audits themselves and contract the job with a reputable consulting group.  Many companies are finding that this…

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