2nd Medical Devices: Regulatory and Compliance Summit
20-21

February 2020

Austria

Vienna

Meliá Vienna

Donau City Strasse 7, 1220

About

There’s less than one year left to EU MDR implementation. Are you ready? This process can be complex and challenging, and the 2nd Medical Devices: Regulatory and Compliance Summit is here to help. This two-day event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. Held on February 20-21, 2020, in Vienna, Austria, this Summit will shed light on classification, conformity assessment and risk management in regulatory strategies to achieve com...

There’s less than one year left to EU MDR implementation. Are you ready? This process can be complex and challenging, and the 2nd Medical Devices: Regulatory and Compliance Summit is here to help. This two-day event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. Held on February 20-21, 2020, in Vienna, Austria, this Summit will shed light on classification, conformity assessment and risk management in regulatory strategies to achieve compliance and ensure patients’ safety. 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. Besides sharing best practices, this event offers a valuable opportunity for network­ing and partnering with businesses of diverse sizes and types. We are excited to be hosting this event and we look forward to meeting you in Vienna!

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Who Should Attend

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

  • Medical Devices
  • Controls & Robotics
  • In Vitro Diagnostics
  • Device Design
  • Medical Device Design
  • Sterilization
  • Product Quality
  • Regulatory Affairs
  • Research & Development
  • Validation
  • Combination Products
  • CMC
  • Design Controls
  • Device Development & Manufacturing
  • Medical Device Engineering
  • Quality Assurance/Control
  • Compliance
  • Risk Management
  • Supply Chain
Key Practical Learning Points of the Summit

Overview of new guidelines, regulations and registration requirements
Notified body feedback on EU MDR implementation
Clinical affairs: data, evidence, equivalence and performance studies
Achieving a smooth market access
UDI implementation: challenges and opportunities
Risk management changes
Engaging medical device manufacturers with cybersecurity requirements
Practical insights from medical device manufacturers
Updating technical documentation and labelling
Classification of medical devices
Post-marketing adverse event reporting
Speakers
Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Matthias Bürger, CH

Vice President of Global Regulatory Affairs

Zimmer Biomet

Dr. Anthony Wilkinson, DE

Global Director for clinical focus team / Head of clinical centre of excellence

TÜV SÜD Product Service GmbH

Dr. Joachim Wilke, GE

Director Regulatory Intelligence EMEA

Medtronic GmbH

Dr. Weiping Zhong, US

Global Director, Risk Management/QARA, Clinical Evaluation, Cybersecurity Safety Risk, Statistics

GE Healthcare

Michel Marboeuf, FR

Sr. Director RA Corporate

Stryker

Fabien Roy, BE

Partner

Hogan Lovells International LLP

Frank Matzek, DE

Vice President Regulatory and Governmental Affairs

BIOTRONIK SE & Co. KG

Sebastian Payne, UK

Director & Life Science Leader

Deloitte

Dr. Philippe Auclair, BE

Senior Director of Regulatory Strategy

Abbott Quality & Regulatory

Koen Cobbaert, BE

Senior Manager - Quality, Standards & Regulations

Philips

Dr. Juliette Cook, CH

Regional Regulatory Director EMEA

Cochlear AG

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