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.

Electrical Safety for Active Medical Devices: The IEC 60601-1 Standard
Medical devices that have an electrical power source must meet special safety requirements. The standard IEC 60601-1 describes these requirements and is therefore one of the most important and most extensive standards for medical devices.
Software Life Cycle for Medical Devices: IEC 62304
In this article, we discuss what manufacturers must pay attention to when considering the software lifecycle and how the standards specifically help in this respect.
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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