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

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

International Standards Medical Devices Links and Tipps

Regulatory Requirements for Medical Devices Regulatory requirements for medical devices  include all legal, normative, and governmental...

Poor Data Quality lead to High time loss for experts in norm interpretation Very high costs for maintaining traceability High compliance...