Overview of the current changes to the Medical Device Regulation (MDR). We collected all helpful data within the ColabON tool. This involved

The Importance of Effective Labeling Labeling is a critical aspect of medical device development and regulatory compliance. A clear,...

Have your medical devices assessed for compliance and tackle the challenges of the EU-AI Act efficiently. We’re offering up to 3...

SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 What is the...

In the highly regulated world of medical devices, staying compliant with ever-evolving regulatory requirements is critical for...