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.

Post market surveillance and vigilance of medical devices according to MDR
Manufacturers of medical devices must monitor their products on the market. The European Medical Device Regulation requires manufacturers to systematically and actively collect information on product use after it has been placed on the European market.
Quality management for medical devices: ISO 13485
The quality management system is an essential component of a medical device manufacturer. The European Medical Device Regulation (MDR) has increased the importance of quality management even further.
Medical apps or software: classification and approval as medical device
Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.
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!

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