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This is a preview click here to buy the full publication IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION color inside Medical device software life cycle processes INTERNATIONAL ELECTROMECHANICAL

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What is medical device software software?

Medical device software software is software that is intended to be used for medical purposes, such as diagnosis, monitoring, treatment, or prevention of diseases.

Who is required to file medical device software software?

Manufacturers, distributors, and importers of medical device software software are required to file with the relevant regulatory authorities.

How to fill out medical device software software?

Medical device software software can be filled out by providing information about the software's intended use, features, functionality, risk assessment, and compliance with regulatory requirements.

What is the purpose of medical device software software?

The purpose of medical device software software is to ensure the safety and effectiveness of software used in medical devices.

What information must be reported on medical device software software?

Information such as the software's intended use, features, functionality, risk assessment, and compliance with regulatory requirements must be reported.

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