ISO 13485 - VDE Medical Devices and Software

ISO 13485 “Medical devices – Quality management systems – Requirements for regulatory purposes” specifies requirements for a quality management system for an organization providing medical devices and related services

This international standard has been developed by ISO.

Usability Engineering for Medical Devices: IEC 62366
In this article we discuss how Usability Engineering based on IEC 62366 leads to a better and compliant medical device.
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.
Legal Requirements for Medical Software
Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.
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!
Traceability of Medical Devices
Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.

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