CHANGES TO ISO 14971 IN THE 2007 VERSION

Excel Partnership has produced a free document highlighting changes to ISO 14971 (Application of risk management to medical devices) from the 2001 version.

ISO 14971 has been revised and was published as the 2007 version in March 2007. The changes are generally about giving greater guidance to companies using standard and will improve the risk management process. Some of the changes will require modifications to company systems and are detailed in this document.

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ISO14791 Changes to 2001 version
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