The recent publication of the MD and IVD Regulations last May has confirmed the continued strong role of robust Quality Management Systems for the design, production and all the post market activities of medical devices and In Vitro Diagnostic devices.
The standard which still remains at the core of the QMS systems for medical devices is ISO 13485 but the new revision published in 2016 and the implementation of the MDSAP program – a must for Canada from January 2019 onwards - oblige manufacturers to take a deep look into their current QMS and to see how they can be updated in order to reflect these requirements.
This presentation will highlight some of these requirements.
Dr. Maurizio Suppo
Co-owner & Principal Consultant
QARAD - BVBA
B-2440 Geel - Belgium