หลักสูตร Medical Devices

Implementation of European Medical Device Regulations is the primary requirements while demonstrating the compliance to regulatory requirements while placing the products in European Market for the Medical Device manufacturers and to place CE marking on the products. The European Council Directives 90/385/EEC and 93/42/EEC has been revised to Regulation (EU) 2017/745. European Medical Devices Regulation (MDR), was published in the Official Journal of the European Union on May 5, 2017. The Regulation (EU) 2017/745, covers medical devices and active implantable medical devices.

***SGS also provide e-certificate and e-document (e-document will be provided for In-house training only). This enables leaners to be free from certificate loss, to reduce storage space, and ultimately to be environmental-friendly to which SGS’s current policy is attached.***