Your expert for the assistance and implementation of regulatory requirements of the MDR (EU) 2017/745 in Europe

:You know your Challenges

  • You need to update your technical documentation
  • The quality of your clinical data is not sufficient
  • The new labelling requirements regarding UDI-DI/UDI-PI and the requirments on the Basic UDI-Di are challenging your team
  • Your PMS System must be updated
  • What is PMCF? What does it mean for you?
  • What data needs to go into the new EUDAMED database?
  • You don't have sufficient personnel or other resources
  • The MDR is so complex and in many ways so confusuing. You need a sparing partner?

I offer :

  • Training sessions as class-room training
  • Workshops (in-house or online)
  • Webinars on various topics
  • ad-hoc support (phone or video calls)


You want to learn more about specific topics ? Here are some proposals:
  • UDI-Requirements
  • Training on EUDAMED database
  • What about OEM ?
  • New requirements on the PMS system
  • What about trend reports? 
  • and more .....

Dipl.-Ing. Hans-Heiner Junker


Experte on regulatory topics in the medical device field

Profile


I have been working in the field of medical technology for over 40 years.


I advise economic operators within the scope of EU Regulation 2017/745. Questions about the approval of medical devices are my specialty.


2020 - now

  • After being retired in 2020 I am offering support and training on various topics focusing on the implementation of the MDR


2002 - 2020

  • TÜV Süd Product Service GmbH, Munich
  • Various roles as:
  • Certification Manager
  • Representative to European Commission, MDCG
  • Technical Certifier
  • Auditor according to MDR and ISO 13485


2008 - 2020

  • Representative to Team-NB
  • Vice President of Team-NB
  • Chairman of NB-Med in Brussels


1999 - 2002

  • Regional Operations Manager of the Test laboratory of TÜV Süd America Inc in Boulder, Colorado


1989 - 1999

  • Auditor according to MDD and ISO 9001/EN 46001
  • Certified expert on medical devices


1980 - 1998

  • TÜV Hannover e.V.
  • Certified expert on medical devices
  • Department Manager Medical Devices
    

1976 - 1980

  • Study of Bioengineering in Hamburg


Hans-Heiner Junker

48465 Schüttorf