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Speaker Profile
FRANK STEIN

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.


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Showing 1 to 4 of 4 (1 Pages)
$200.00
EU MDR-Introduction into The European Medical Device Regulation

 Frank Stein
 Recorded Webinar
 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..

$200.00
Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?

 Frank Stein
 Recorded Webinar
 90 Minutes
 Download Catalog
Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?

The EU MDR 745/2017 is a complete game-changer 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..

$200.00
STED - File: How to Improve Your Technical File

 Frank Stein
 Recorded Webinar
 90 Minutes
 Download Catalog
STED - File: How to Improve Your Technical File

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..

$200.00
The New ISO 14971 - How to Create a Risk File for Medical Devices

 Frank Stein
 Recorded Webinar
 90 Minutes
 Download Catalog
The New ISO 14971 - How to Create a Risk File for Medical Devices

This course will give an introduction into the new ISO 14971 and how to create a risk management file according to the ISO 14971. The course will give you an overview of the requirements and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.Areas CoveredWhat is the Medical Device Single Audit Progr..

Showing 1 to 4 of 4 (1 Pages)