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2nd Medical Devices: Regulatory and Compliance Summit

  • 20th – 21st February 2020
  • Austria flag Austria Vienna
  • Meliá Vienna Donau City Strasse 7, 1220

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.

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About

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.

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

  • 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

Matthias Bürger, CH

Vice President of Global Regulatory Affairs

Zimmer Biomet

Matthias Bürger is the vice president of Global Regulatory Affairs for Zimmer Biomet, the European subsidiary of Zimmer Holdings. He has a master’s in biomedical engineering from Marquette University in Milwaukee, WI, as well as a Dipl.-Ing. degree in electrical engineering from Fachhochschule Dieburg in Germany. In the past, Matthias has had a variety of different management roles in QA and regulatory affairs for companies including GE, Baxter, Terumo and Guidant. He has also worked as a quality management systems and operational consul­tant for Grant-Thornton, as well as spending time as a lead auditor and test engineer for TUV Rheinland, a European notified body for the Medical Device Directive. Matthias has spoken at a variety of international conferences, including RAPS, MD&D, ASQ, IEEE and others.

Nurcan Coskun, CH

Healthcare Lead

Meddg

Dr. Nurcan Coskun Over 20 years of clinical experience working with Fortune 100 companies in MedTech and Pharma as well in academia. She has a proven track record of the transformational project and team leadership, risk and change management, successful implementation of technological solutions including vendor management. After obtaining her Ph.D. degree in Cancer Epidemiology at Oncology Institute in Istanbul, she completed her master’s degree in Medical Informatics at Erasmus University, Rotterdam in the Netherlands. SOP writing, training, publications, leading task forces on different topics are the areas she has experience. Her current focus is on the Risk-Based Approach to Clinical Trials and digital transformation and innovation in Healthcare. Nurcan is an author and contributor for whitepapers in the field of RBM as well in epidemiology. Attends conferences as speaker and panelist.  

Giacomo Cargnello, NE

BG DI EU MDR Program Head

Philips Medical Systems Nederland B.V.

Giacomo Cargnello is currently the Program Lead and Principal SME of the MDR implementation for the entire Business Group Diagnostic Imaging (BG DI) of Philips, covering multiple modalities (e.g. MR scans, CT devices, Fluoroscopy and Digital Diagnostic devices and SW products) in 8 different sites around the world. He is also part of the Corporate Pre-Market Task Force which provides interpretation and guidance related to the MDR across all Philips Business Units. Giacomo Cargnello holds a Master’s Degree in Biomedical Engineering (MSc/MEng) and he has worked in several medical device industries covering different Q&R roles: prior to Philips MRI, he was RA Man- ager at Philips IGT (Interventional X-Ray manufacturer). Before Philips, he worked at Baxter Healthcare starting as QA/RA R&D Project Manager and later APAC/Americas RA Manager, dealing with the regulatory activities of HaemoDialysis equipment in these two regions. He has also worked in St. Jude Medical (now Abbott Laboratories) in the implantable pacemaker and defibrillator division. In addition, he is a certified Philips Q&R Auditor and Lead Auditor for the Medical Device Directive 93/42/EEC, ISO 13485, ISO 9001, FDA QSReg, Canadian MDR (SOR-98-282) and Japan’s Pharmaceutical and Medical Device Act (jPMD Act).  

Dr. Joachim Wilke, GE

Director of Regulatory Intelligence EMEA

Medtronic GmbH

Dr. Joachim Wilke studied biology at the University of Konstanz and received his doctorate in immunology. Later, he completed his education through a postgraduate MSc degree in pharmacological medicine at the University of Essen-Duisburg. Joachim has held positions in clinical research and regulatory affairs since 1986, starting at Dornier Medizintechnik GmbH and moving to Medtronic in 1993, when he headed the Technical-Scientific Service and by 2001 became responsible for regulatory, quality and compliance for Germany, Austria and Switzerland. During this time, he was also spokesman for the regulatory and public affairs (AKRP) working group of the BVMED for several years, to which he still belongs today as a permanent member and deputy chairman. Since 2009, Joachim has been director of regulatory and policy at Medtronic EMEA. In this function, he pursues new legislative procedures for medical devices and is responsible for their interpretation with regard to implementation in the company. He is acting chairman of the regulatory affairs committee (RAC) of MedTech Europe.  

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Elizabeth Gfoeller is the corporate director of regulatory affairs for MED-EL, which is an EU manufacturing company privately owned and operated out of the same location. All functions (design, manufacture, distribution, etc.) are located in the head office in Innsbruck, Austria. MED-EL is active in over 115 markets worldwide with over 30 regional offices. As the leading global hearing implant company, MED-EL manufactures active implantable medical devices, namely cochlear implants, middle ear implants and bone conduction implantable and other non-implantable hearing systems and surgical devices that are marketed globally. Elizabeth joined MED-EL in 2006 and currently leads the corporate regulatory affairs function responsible for all markets for product licensing, registrations/re-certifications, post-market vigilance ac­tivities, regulatory strategies for new product developments and related compliance activities internally and externally to new regulations and standards. She acts as the responsible person for communication with regulatory agencies and engages in lobbying activities. Before this role in medical devices, she worked as a regulatory professional in the telecommunications sector at Vodafone Ireland from 2000 until 2005 as a regulatory compliance manager and a data pro­tection officer located in their head offices in Dublin. Prior to this, Elizabeth spent many years active as both a lecturer and social researcher in South Africa. Her educational background is in social sciences, with her studies and thesis focussed on sociology. Her graduate and post-graduate studies were completed at the University of the Witwatersrand, South Africa.

Michel Marboeuf, FR

Sr. Director, RA Corporate

Stryker

Michel is a Regulatory Affairs Senior Director Corporate He has been working for Stryker for 25 years in different Regulatory affairs and Quality leadership role, leading France, Europe and Emerging markets, in various regulatory environment leading large team with different cultures. Currently Michel is a interpretation workstream lead for the EU MDR program, leading Advamed working group and participating actively to the MedTech Regulatory Affairs Committee and advocacy strategic working group He is also leading several global Quality projects and has leadership experience in clinical and operations. He has a MBA and graduated from a Business School in Paris as a Master in Quality.  

Hélène Boland, BE

Associate

Hogan Lovells International LLP

As an associate in the life sciences practice, Hélène Boland advises clients on European Union and national regulation of medical devices and pharmaceutical products. She assists clients in the different phases of the application process for marketing authorisation of medicinal products and related post-marketing activities and the conformity assessment process for medical devices. Hélène follows the new regulations on medical devices (MDR and IVDR) very closely and regularly advises clients on the requirements applicable to their digital health technologies. Hélène focusses particularly on guiding clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. Hélène also assists clients in the preparation, drafting and review of numerous agreements, including clinical study agreements, sponsors’ representative agreements, registry agreements, CRO agreements, European authorised representative agreements and distribution agreements.

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.  

Sebastian Payne, UK

Director & Life Science Leader

Deloitte

Sebastian Payne is a director at Deloitte specialising in life science risk advisory, and he has over 19 years of experience in LSHC consultancy. He leads Deloitte CORE (Centre of Regulatory Excellence for Life Science), a global initiative that supports life science companies in implementing systems and processes for current and emerging life science regulation. Since June 2014, Sebastian has also led Deloitte’s business services collaboration with EMA and has overseen a number of Deloitte-supported projects at the agency.  

Dr. Philippe Auclair, BE

Senior Director of Regulatory Strategy

Abbott Quality & Regulatory

Philippe Auclair, who has a PhD in pharmacy, joined Abbott in 1994. He is currently respon­sible for regulatory strategy and advocacy. He represents the European industry in various European Commission expert groups and served through 2012 as secretary of the Global Harmonization Task Force Study – Group 2, dealing with adverse events reporting. He actively participates as a trainer in programs organised by regulatory authorities in various locations, such as Europe, Colombia, Brazil, China, India, Mexico and the United States, and since 2015 he has served as an advisor to the Asian Harmonization Working Party Technical Committee.

Philippe is chairman of the post-market surveillance and notified body working groups of Medtech Europe, the European medical device manufacturers’ trade association. He is a mem­ber of the European Advisory Committee and of the board nominating committee of the Regu­latory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010 and was elected “RAPS Fellow” in 2012. Philippe is also the proud recipient of an FDA CDRH Director’s “Special Citation” for his work at GHTF.

Koen Cobbaert, BE

Senior Manager – Quality, Standards & Regulations

Philips

Koen Cobbaert represents COCIR at the European Commission in the MDCG work groups on Borderline and Classification and on New Technologies. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industry. He has been chairing COCIR’s Software Focus since 2009. He for example drafted the qualification decision tree in MEDDEV 2.1/6 regarding stand-alone software. Today his focus group works on the interpretation of the EU Medical Device Regulation for software products, covering aspects such as machine learning, the responsibilities of app stores and cybersecurity. Koen is the author of several position papers pertaining software, all published through COCIR. Koen Cobbaert has over 15 years of hands-on experience in establishing regulatory strategies for market-access, writing technical files and 510(k)s, performing worldwide regulatory submissions and moderating risk management and clinical evaluation discussions for software applications for general radiology, oncology, neurology, cardiology and orthopaedics, computer algorithms for pattern recognition, computer aided detection, reasoning engines, decision support, clinical pathways, general systems such as HIS, LIS, IVD, PACS, EPR and mobile apps. In relation to software standards Koen Cobbaert contributed to the development of IEC 82304 on safety requirements for health software and IEC 62304 on software lifecycle processes. He also co-authored the FAQ on IEC 62304, which has been translated in several languages. He acts as Belgian expert in JWG7 of IEC 62 on Electrical Equipment in Medical Practice and in CEN/IEC251 on Health Informatics. Today he contributes to the development of principles for health and wellness app developers to follow throughout an app project life cycle, so that health care professionals, patients and the public trust their products and services and he preparing a new work item on adaptive intelligence and machine learning. Currently Koen Cobbaert works for Philips Healthcare as Senior Manager – Quality, Standards and Regulations. Koen Cobbaert has a Master in Electrical Engineering and a Master after Master’s in Risk Management.  

Dr. Juliette Cook, CH

Regional Regulatory Director EMEA

Cochlear AG

Juliette joined Cochlear Limited in 2017, heading the Regulatory Affairs function for the Europe, Middle East and Africa Region. Cochlear is a leading global medical device company that provides implant solutions to restore hearing. She is leading project activities to ensure compliance to the new Medical Device Regulation. Prior to this she spent nearly 7 years at Rayner Intraocular Lenses as Director of Quality and Regulatory Affairs, managing the team responsible for global regulatory, quality and the company’s clinical programme. She was involved in key strategic projects including the construction and transfer to a new manufacturing facility, Notified Body change, new product development, quality remediation, company acquisitions and of course the MDR. Previous roles include leading Regulatory Affairs with Zimmer in Switzerland, most notably the project to up-classify hip, knees and shoulders to class III. She has had diverse roles in managing research and development, quality management systems, medical device management and leading regulatory affairs teams both in the UK and overseas in developing countries, from big multinationals, to tiny companies. She is a Chartered Mechanical Engineer, member of the Regulatory Affairs Professional Society and has been an active member of MedTech Europe and ABHI. She has a Doctorate qualification in Biomedical Engineering and has worked in Industry and the Global Healthcare Sector for over 20 years.  

Reinhard Berger, AT

Training & Development Consultant

Annelies Vertommen, BE

Team Leader of Medical Device, Chemical Characterisation & Compendial Testing

Nelson Labs Europe

Annelies Vertommen holds a master in Biology and a PhD in Bio-Engineering. She started her career at Nelson Labs as study director for extractables and leachables projects, gaining experience in the different application fields of the pharmaceutical industry. During the last years she focused on chemical characterization studies for the medical device industry. She is team leader of a group of study directors specialized in the set-up of studies according to ISO 10993-18 in the broader context of ISO 10993-1. She also is member of the ISO 10993-18 and ISO 10993-17 expert panel.

Matthias Bürger, CH

Vice President of Global Regulatory Affairs

Zimmer Biomet

Nurcan Coskun, CH

Healthcare Lead

Meddg

Giacomo Cargnello, NE

BG DI EU MDR Program Head

Philips Medical Systems Nederland B.V.

Dr. Joachim Wilke, GE

Director of Regulatory Intelligence EMEA

Medtronic GmbH

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Michel Marboeuf, FR

Sr. Director, RA Corporate

Stryker

Hélène Boland, BE

Associate

Hogan Lovells International LLP

Frank Matzek, DE

VP of Regulatory & 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

Reinhard Berger, AT

Training & Development Consultant

Annelies Vertommen, BE

Team Leader of Medical Device, Chemical Characterisation & Compendial Testing

Nelson Labs Europe

Sponsors

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

“Thank you for all your work”

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Susanne Wyss-Lanz

Ypsomed

“Great Organization”

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Falko Klein

Nobel Biocare