• Your shopping cart is empty!

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.


Product Compare (0)
$179.00
HACCP - How to Create a HACCP-Concept Including COVID19 Disease Related Requirements and How to Deal with CP's and CCP’s?

 Frank Stein
 August 10 2020
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
HACCP - How to Create a HACCP-Concept Including COVID19 Disease Related Requirements and How to Deal with CP's and CCP’s?

The HACCP methodology as risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintenance HACCP files documentation and find and define the check points (CP) and critical check points (CCP) in material flow from goods in control over the manufacturing steps until the final goods storage. which is mandatory for ph..

$179.00
How to Certify Reprocessing Surgical Instruments According the Risk Class Ir in Europe?

 Frank Stein
 September 21 2020
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
How to Certify Reprocessing Surgical Instruments According the Risk Class Ir in Europe?

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..

$179.00
Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in your Company Required by the EU MDR Regulation

 Frank Stein
 October 05 2020
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
Responsible Person Article 15 EU MDR 2017/745 - A New Mandatory Role in your Company Required by the EU MDR Regulation

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company ..

$179.00
How to Create a PMS Plan and Report According EU MDR 2017/745 Article 83-86?

 Frank Stein
 November 09 2020
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
How to Create a PMS Plan and Report According EU MDR 2017/745 Article 83-86?

You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system according to ISO 13485:2016 like a post-market-surveillance plan and report and how to create the annual PSUR – Performance Safety Update Report to the Notified Bodies and EUDAMED in a simple and quick way. Your implementation..

$179.00
How to Create a Technical Documentation According EU MDR 2017/745 Annex II and III?

 Frank Stein
 December 07 2020
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
How to Create a Technical Documentation According EU MDR 2017/745 Annex II and III?

This course will give an introduction to the European Medical Device Regulation. The introduction will give an overview about the structure, term definitions, the requirements for the technical documentation, how a smart implementation of these requirements in the quality management system and the technical documentation is possible and how Annex II and III are connected to the other annexes e.g. XIV for cl..

Showing 1 to 9 of 9 (1 Pages)
$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
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..

$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
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..

Showing 1 to 9 of 9 (1 Pages)