Medical Devices, Consultancy

ISO 13485:2016 Consultancy ISO 13485 Background

ISO 13485 specifies the requirements for a quality management system for medical devices. In the medical devices industry, organization have to comply with the customer requirement and most importantly, meeting the applicable regulatory requirements relevant to the specific medical devices.

GDPMD is the Regulatory requirements for Medical Device Safety & Performance. In the Medical Devices Regulation 2012, Appendix 4 – Requirements on the Quality Management System, it specifies that Authorized Representative, Importer and Distributor is required to certify under GDPMD.