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UNE-EN IEC 62304

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UNE-EN IEC 62304

We provide solutions that guarantee compliance with UNE-EN IEC 62304.

The challenge

UNE-EN IEC 62304 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. It applies to the development and maintenance of medical device software when the software is itself a medical device or when the software is an integral or integrated part of the final medical device. This standard does not cover the validation and final version of the medical device, even when the medical device consists entirely of software.

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