ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence

The international standard ISO 13485 (ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes) for a quality management system (QMS) is recognised globally to address minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements for manufacturers and suppliers of medical device and IVDs, and it establishes a minimum quality assurance framework to ensure medical devices and IVDs are managed appropriately with the intention to provide medical device and IVDs which are safe and perform as intended by the manufacturer.