Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
June 10 2019
03 : 00 PM EST
The EU MDR 745/2017 is a complete game change to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show how to conduct a gap-analysis, an action plan and how to be on track until May 2020. Learn what to do into the quality management department and what to do in the regulatory affairs de..
June 20 2019
01 : 00 PM EST
The Risk-File according to ISO 14971 and how to deal with this file regarding the several requirements in countries, which require Risk-Files according to ISO 14971 e,g, Europe, MDSAP-Countries (_AUS, BR, CAN, JP, US). Another topic is how to deal with the ISO 14971 regarding the new EU MDR in Europe at 2020 how to be prepared for technical file submissions beginning this summer 2019 in Europe. Learn how to..