Medical Devices: Regulatory and Compliance Summit
20-21

February 2019

Austria

Vienna

About

We would like to welcome you to the Medical Devices: Regulatory and Compliance Summit on February 20th-21st, 2019, in Vienna, Austria. This event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. The 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 le...

We would like to welcome you to the Medical Devices: Regulatory and Compliance Summit on February 20th-21st, 2019, in Vienna, Austria. This event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. The 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. We are looking forward to your participation this February in this engaging Summit in Vienna!

more info
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 guidelines, regulations and registration requirements
Quality management systems
Clinical affairs: data, evidence, equivalence and performance studies
Achieving a smooth market access
MDR impact on risk management and clinical evaluations
Updating technical documentation and labelling
Requirements for classification of medical devices
Higher patient safety at what price?
Post-marketing adverse event reporting
Speakers
Dr. Bassil Akra, DE

Vice President – Global Focus Teams / Active Implantable, Cardiovascular, Orthopedic, Aesthetic Devices & Clinical

TÜV SÜD Product Service GmbH

Dr. Philippe Auclair, BE

Senior Director of Regulatory Strategy

Abbott Quality & Regulatory

Matthias Bürger, CH

Vice President of Global Regulatory Affairs

Zimmer Biomet

Giacomo Cargnello, NE

Sr. Regulatory Affairs Manager & EU MDR Lead

Philips Medical Systems Nederland B.V.

Anna Mirabelli, DE

Scheme Manager & Technical Expert, Healthcare

BSI

Elizabeth Gfoeller, AU

Corporate Director, Regulatory Affairs

MED-EL GmbH

Dr. Erik Raadsheer, NE

Sr. Director Regulatory & Government Affairs & Quality Assurance EMEA

Align Technology EMEA

Pedro Jorge Mendes, ES

Technical Steward Devices / Novartis Technical Operations – SOLIDS Platform

Novartis Farmaceutica S.A.

Dr. Weiping Zhong, US

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

GE Healthcare

Fabien Roy, BE

Counsel

Hogan Lovells International LLP

Bijan Elahi, NE

Global Product Risk Management Consultant, Educator

Medtronic

Dr. Clemens Guenther, DE

Director of Nonclinical Safety CC

Bayer AG