B114 - CE Marking & Other EU/International Regulations

This course will cover all aspects of CE Marking Requirements with an emphasis on medical device regulations for the EU. Overview • The new Medical Device Regulations (MDR) released in May, 2017 • Quality System Requirements- ISO 13485 and Medical Device Directive (93/42/EEC) • Risk Management- ISO 14971 • The EC Directive process and CE marki