IEC 62304 - VDE Medical Devices and Software

IEC 62304 “Medical device software – Software life cycle processes” defines the life cycle requirements for medical device software. The set of processes, activities, and tasks establishes a common framework for life cycle processes.

This international standard has been developed by IEC.

Software Life Cycle for Medical Devices: IEC 62304
In this article we give an overview of the software life cycle of medical devices and the corresponding standards.
Market Access for Medical Devices and Software
VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.
Technical Documentation: See the Opportunities, not the Challenges!
The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!
Cyber Security Threats in Healthcare
Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.

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