Traceability - VDE Medical Devices and Software

Traceability of medical devices is closely linked to the Unique Device Identification system (UDI system). The aim is a better market transparency and product identification through out the entire life cycle.

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.
The EU Medical Device Regulation (MDR): What is changing?
The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.
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.
Market Access for Artificial Intelligence in Medicine
How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.
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.

« Back to Glossary Index