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4th Medical Devices Regulatory and Compliance Hybrid Summit

  • 23rd – 24th February 2022
  • Hybrid flag Hybrid
  • Berlin

This two-day event will shed light on the most important and relevant medical device regulation topics. Through case studies, interactive presentations, and discussions, attendees will learn which regulatory strategy is applicable for their products, how to develop effective tactics, and how best to achieve smooth market access.

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4th Medical Devices Regulatory and Compliance Hybrid Summit, February 2022

The EU MDR became applicable last May. However, there are still plenty of questions regarding the future development of regulations. How should you navigate the potentially catastrophic bottleneck at notified bodies? What's the timeline and process regarding UDI and EUDAMED? What impact will the draft EU Artificial Intelligence Act have on health care?

The 4th edition of the Medical Devices Regulatory and Compliance Summit is here with the most up-to-date hybrid format.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists and Engineers specialising in:

  • CMC
  • Combination Products
  • Compliance
  • Controls & Robotics
  • Design Controls
  • Device Design
  • Device Development & Manufacturing
  • In Vitro Diagnostics
  • Medical Devices
  • Medical Device Design
  • Medical Device Engineering
  • Product Quality
  • Quality Assurance/Control
  • Regulatory Affairs
  • Research & Development
  • Risk Management
  • Sterilisation
  • Supply Chain
  • Validation

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Overview of guidelines, regulations, and registration requirements
  • What's the price of higher patient safety?
  • UDI and EUDAMED
  • Notified body feedback on EU MDR implementation
  • MDR impact on risk management and clinical evaluations  
  • Clinical evidence requirements
  • Requirements for classification of medical devices
  • Quality management systems
  • Achieving smooth market access
  • Practical insights on MDR implementation from medical device manufacturers

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.  

Martin Witte, DE

Senior Director - Strategic Business Development / Medical Health Services

TÜV SÜD Product Service GmbH

Martin Witte is Senior Director Strategic Business Development for the Medical Health Service business at TÜV SÜD and responsible for strategic topics such as Active Medical Implants, Cardiovascular, Orthopaedic, and Functional Safety/Software.

Prior to his current role, Martin was a Lead Auditor and Product Specialist for high-risk devices. Prior to TÜV SÜD, Martin worked on the industry side for 6 years as a Regulatory Affairs Manager with BIOTRONIK, focusing on heart rhythm management devices and MRI safety of active implantable devices. Martin is a strong supporter of digitalization in the Medtech world.

Khaudeja Bano MD., USA

Executive Medical Director, Head of Combination and Device Product Safety

Amgen

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator, and a certified Project Management Professional.

Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical/clinical and safety leadership roles in devices, diagnostics, pharmaceuticals, and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Elizabeth Gfoeller is the Corporate Director of Regulatory Affairs for MED-EL, a privately owned EU manufacturer of hearing implantable solutions in Innsbruck, Austria. MED-EL is active in over 115 markets worldwide with over 30 regional offices. MED-EL manufactures and globally markets the most comprehensive portfolio of hearing solutions for people with all types of hearing loss ranging from cochlear implants, middle ear implants, auditory brainstem implants, bone conduction implants, passive middle ear implants to non-implantable hearing systems. After completing her post-graduate studies in Sociology at the University of the Witwatersrand in South Africa, Elizabeth spent several years acting as both a lecturer and social researcher in post-Apartheid South Africa. From 2000 till 2005, she moved into the telecommunications sector with responsibility for Regulatory Compliance and acted as Data Protection Officer in Vodafone Ireland. Joining MED-EL in 2006, she currently leads the Corporate Regulatory Affairs function in HQ responsible for all markets for product licensing, registrations/re-certifications, post-market vigilance activities, regulatory strategies for new product and change developments, and related compliance activities internally and externally to new regulations and standards. She acts as the responsible person for communication with all relevant regulatory agencies and engages in lobbying activities. 

Markus Pöttker, CH

Post Market Surveillance Lead

Smith & Nephew

Frank Matzek, DE

VP of Regulatory & Governmental Affairs

BIOTRONIK SE & Co. KG

Martin Witte, DE

Senior Director - Strategic Business Development / Medical Health Services

TÜV SÜD Product Service GmbH

Khaudeja Bano MD., USA

Executive Medical Director, Head of Combination and Device Product Safety

Amgen

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Markus Pöttker, CH

Post Market Surveillance Lead

Smith & Nephew

BROCHURE  

Request the 4th Medical Devices Regulatory and Compliance Hybrid Summit, February 2022 brochure and find out the latest topics and ideas that will be shared.

Request

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