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ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package

ISO 13485, IEC 62304 and ISO 14971 - Software, Quality and Risk Management of Medical Devices.

The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software. The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes:
IEC 62304 Ed. 1.0 b:2006
IEC 62304 Amd.1 Ed. 1.0 b:2015
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO 14971:2007
ISO/DIS 14971:2018

ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package includes:

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International Organization for Standardization [ISO]


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