A quality management system (QMS) compliant with ISO 13485 is mandatory for manufacturers of medical devices and IVDs. Without ISO 13485...

ColabON's Regulatory Change and Impact Analysis Accelerates and Improves Compliance Assessment Regulatory Change- and Impact Analysis...

EU AI Act and Medical Devices:  The European regulation for artificial intelligence must also be applied to medical devices. With Prof....

In the medical device industry, balancing compliance costs  with the need for speed and innovation is a constant challenge. How does your...