Prof. 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.
November 15 2019
01 : 00 PM EST
The STED-File with the special format as technical documentation covers a lot of countries and help to have technical documentation in global acting companies. A STED-File collect all the data’s and can help you to keep the overview to deal with this format regarding the several requirements in countries, which required STED-Format e.g. Australia, Canada, etc. Another topic is how to deal with the STED-Form..
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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..