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Live Event

EU MDR Compliance

  • 14th May 2020
  • Webex flag Webex
  • ONLINE

This webinar is designed for industry leaders and regulatory professionals to discuss the current state of MDR implementation and regulatory strategy. During the webinar, you will have a unique opportunity to discuss the burning questions with our experts.

What is the current state of MDR Implementation? How to meet the new deadline and what are the goals during the COVID-19 pandemic? The brochure contains the key insights of the live event

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About

Five experts in the medical field will host our live EU MDR event on 14 May 2020, and you will have the opportunity to discuss with them the burning questions regarding:

-MDR proposed changes and recent guidance on regulatory audits

-Status of MDR implementation

-The emergency rules relating to COVID 19

Each session will be followed up with a time slot for interaction with the speakers and the possibility to ask any questions. Two of the speakers will join in the last part of our Live Event to share a case study on the lessons learned from the EU MDR Implementation at their Company.

Our company has garnered vast experience over the years, creating quality conferences and summits, that provide our participants with innovative ideas. 

In 2020, to keep up with the evolving digital world, we are delighted to present you with a series of Live Events

You will receive a digital Certificate of Attendance after the event!

 

Who should attend?

  • Medical Devices
  • Combination Products
  • CMC Device Development & Manufacturing
  • Quality Assurance & Control
  • Product Quality
  • Compliance
  • Regulatory Affairs
  • Risk Management
  • Research & Development
  • Validation

KEY PRACTICAL LEARNING POINTS

  • MDR proposed changes and Recent Guidance on Regulatory Audits 
  • Status of the MDR  Implementation 
  • How to work with emergency rules relating to COVID-19?    
  • Lessons learned from the case study - EU MDR implementation at Getinge Group 

Frank Matzek, DE

VP of Regulatory & Governmental Affairs

BIOTRONIK SE & Co. KG

Vice president of regulatory governmental affairs at BIO-TRONIK in Berlin, Germany.

BIOTRONIK is a leading global medical device company with products and services that save and improve the lives of patients suffering from cardiovascular and endovascular diseases.

Frank holds a Dipl.-Ing. degree in biomedical engineering from the Technical University of Berlin, he’s a certified quality engineer and he has received a degree in business and administration. Frank began his career in 1984 at the test and certification body for medical devices at the Technical University of Berlin and in 1992 he moved to industry as a senior manager of regulatory affairs, assuring BIOTRONIK’s first CE-Mark for an active implantable device in 1993.

After serving as vice president OEM from 2000, Frank became VP of regulatory and governmental affairs in 2016. In addition to his role with BIOTRONIK, Frank is actively involved in MedTech Europe as a member of various work groups, the MDR steering committee and the regulatory affairs committee.  

Dr. Bassil Akra, DE

Vice President Strategic Business Development / Global Medical Health Services

TÜV SÜD Product Service GmbH

Dr. Bassil Akra is Vice President Strategic Business Development Global Medical Health Services at TÜV SÜD Product Service GmbH, a Notified Body located in Germany. He has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. He is also involved in the development of several European guidance documents and standards. 

Erik Vollebregt, NE

Founder Partner at Axon Lawyers

Axon Lawyers

Specialized in EU regulatory issues relating to medical devices, including eHealth, mHealth and protection of personal data. Active in law and policy development as a committee member of branch associations and the European Commission.  

Axon lawyers focused on legal and regulatory aspects on the life sciences sector. 

Mikael K Johansson, SWE

Senior Director Program Office ACT & EU MDR Acute Care Therapies

Getinge

Through the Program Office for ACT, Johansson has oversight of all projects within ACT aiming at innovation, R&D and EU MDR implementation.  

Holding a Master of Science in Industrial Engineering and Management. Johansson has held several senior leadership positions: VP for various functions for Critical Care in Sweden, Managing Director for the Advanced Monitoring business, and the Cardiopulmonary business within ACT in Germany. 

Karl-Yngve Keck, SWE

Senior Adviser Product Compliance

Getinge

Responsible for communication with Getinge's Notified Body and the transfer of all Getinge companies to the same Notified Bod, and the MDR implementation program. 

Holds a Master of Science degree in Technical Physics with a Medical Engineering degree with more than 25 years of experience in medical technology from Siemens-Elema and Getinge. He has worked with class l to class lll products during all phases of the product life cycle. 

Frank Matzek, DE

VP of Regulatory & Governmental Affairs

BIOTRONIK SE & Co. KG

Dr. Bassil Akra, DE

Vice President Strategic Business Development / Global Medical Health Services

TÜV SÜD Product Service GmbH

Erik Vollebregt, NE

Founder Partner at Axon Lawyers

Axon Lawyers

Mikael K Johansson, SWE

Senior Director Program Office ACT & EU MDR Acute Care Therapies

Getinge

Karl-Yngve Keck, SWE

Senior Adviser Product Compliance

Getinge

What our
participants
are saying

‘’It is an honour to speak at the next MDR conference in Vienna and hear from other colleagues about the different points of view and challenges of the MDR.‘’

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Giacomo Cargnello

Philips

"I enjoyed the conference and found presentations to be very rich and informative. It was also a great networking opportunity. Great Organization ”

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Falko Klein

Nobel Biocare

"Thanks Vonlanthen Group for a well organized and professional event!"

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Susanne Wyss-Lanz

Ypsomed