ISO 13485 • VDE Medical 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.

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.
Harmonized Standards for Medical Software
Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.

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