CE marking certificate compliance with the EU directive
CE certification for Medical Devices, Medical Masks according to directive 93/42/EEC Medical devices - Guidelines for classification of medical devices
The Medical Devices Directive aims to harmonize the laws relating to medical devices in the <Detail>
MDSAP - The Medical Device Single Audit Program
The International Medical Device Regulators Forum (IMDRF)External Link Disclaimer recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. <Detail>