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Speaker Profile
FRANK STEIN

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.


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$229.00
EU MDR-Introduction into The European Medical Device Regulation

 Frank Stein
 June 10 2019
 03 : 00 PM EST    
 90 Minutes
 Download Catalog
EU MDR-Introduction into The European Medical Device Regulation

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..

$229.00
ISO 14971 - How to Create a Risk File for Medical Devices

 Frank Stein
 June 20 2019
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
ISO 14971 - How to Create a Risk File for Medical Devices

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..

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Showing 1 to 2 of 2 (1 Pages)