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3rd Medical Devices: Regulatory and Compliance Online Summit

  • 24th – 25th February 2021
  • Zoom flag Zoom
  • ONLINE

The process of EU MDR Implementation can be complex and challenging, and our online Medical Devices: Regulatory and Compliance summit is here to help. 

This two-day event 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.

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About the 3rd Medical Devices: Regulatory and Compliance Online Summit

We will be streaming exclusively for our attendees, introducing current state of MDR implementation and regulatory strategy.

This webinar was designed for industry leaders and regulatory professionals.

During the webinar you will have a unique opportunity to discuss the burning questions with our experts.

Who Should Attend

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

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

Key Practical Learning Points

  • Overview of guidelines, regulations, and registration requirements
  • Notified Body feedback on EU MDR implementation
  • Clinical Evidence Requirements
  • Achieving smooth market access
  • MDR impact on risk management and clinical evaluations
  • UDI and EUDAMED
  • Requirements for classification of medical devices
  • Higher patient safety at what price?
  • Quality management systems
  • Practical insights on MDR Implementation from medical device manufacturers

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.

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

Ph.D. in Strategy and Organizations, Juan has specialized in regulatory compliance projects for devices and combination products, particularly focusing on the new Medical Device Regulation. Juan both leads and acts as subject matter expert in the MDR-remediation for pharmaceutical clients and the submissions for Notified Body Opinions for drug-device combinations. 

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.

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

CEO

QUNIQUE GmbH

Dr. Bassil Akra is CEO and one of the owners of the QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

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. 

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 within the Philips Cluster Precision Diagnosis, covering 600+ products and 6 different product lines for total revenue of 3.4B€ (e.g., MR scans, CT devices, Fluoroscopy and Digital Diagnostic devices, and SW products) in 8 different worldwide plants and managing a multi-disciplinary team of 30+ people. 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.  

He holds a Master’s Degree in Biomedical Engineering (MSc/MEng), and he worked in different roles with increasing responsibilities within several medical device industries (Philips, Baxter, St. Jude Medical/Abbott) covering different medical equipment (implantable pacemaker and defibrillator, hemodialysis equipment, an image-guided therapy X-ray system, MR, X-Ray, CT and PET scans, and medical software products). 

He is an expert on International Regulations and Standards, being also a certified Philips Lead Auditor and experienced auditee on the EU MDD/MDR, ISO 13485, ISO 9001, FDA QSReg, Canadian MDR (SOR-98-282), and Japan’s Pharmaceutical and Medical Device Act (jPMD Act).

 

Kim Trautman, US

Executive Vice President, Medical Device International Services

NSF International

Kim is an Experienced Medical Devices and InVitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Kim has industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators, and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation. 

Kim is a recognized international expert in global medical device regulations, wrote and harmonized the US FDA Quality System Regulation 21 CFR § 820, and was on the international authoring group of ISO 13485 since inception. While at the US FDA conceived and developed the MDSAP international consortium of five Global Regulators, as well as its many foundational documents. She is a twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF). Also a Medical Device expert on the Center for Drug Evaluation and Research (CDER) "GMPs for the 21st Century Initiative" Steering Committee and on the FDA authoring group for the Combination Product Good Manufacturing Practice (GMP) Part 4 regulation. Kim's last position at CDRH was Associate Director for International Affairs within the Office of the Director. Currently, at NSF International in the Health Sciences Division, Kim is leveraging her over thirty years of medical device sector experience to expand international regulatory affairs and compliance services for NSF International global clients.

Marcia Orozco, US

Associate Director, MDR & Safety Operations

Alcon

Marcia Orozco is an Associate Director of MDR & Safety Operations in the Global Medical Safety group for Alcon. She holds a Master’s degree in Biomedical Engineering from the University of Miami. She started her ca­reer at Innovia LLC in their Research and Development department supporting new product development of ophthalmic and cardiovascular medical devices. She later transitioned to Alcon/Novartis in their Global Device Medical Safety group, where she supported clinical trials and risk management for the surgical and vision care franchises. She transitioned into the MDR leader role while participating in Alcon’s EU MDR initiative. In this role she has implemented tools and procedures to comply with the EU MDR safety reports for all Alcon products.

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.  

Erik Vollebregt, NE

Founder Partner

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. 

Stephanie Göbel, DE

Senior Consultant / Medical Devices & Combination Products

Beyond Conception GmbH

A medical engineer with 15 years of experience in medical devices and combination products, Stephanie is an expert in drug-device combinations. She has joined from TÜV SÜD, where she was a product specialist on Article 117 (MDR) and a member of the respective Team NB (European Association of Notified Bodies) working group. Stephanie leads clients in their transition to the MDR through regulatory analysis, readiness audits/checks, and personalized training.

Dr. Paul van Geffen, NL

Senior Manager | Regulatory Risk | Life Science & Health Care

Deloitte

Deloitte

Paul is a Senior Manager Regulatory Consulting at Deloitte Netherlands with an industry focus on Life Sciences & Health Care. He has 4 years of biomedical research experience and 10 years of industry experience in delivering regulatory compliance, remediation, and transformation projects covering a wide range of medical devices and technologies, including in-depth knowledge of the Medical Device Regulation across the device lifecycle. Paul is an auditor ISO 13485:2016, and he further supports the life sciences industry and regulators with their regulatory policy and with keeping up with the evolving regulatory landscape.

Martin Witte, DE

Senior Director - Strategic Business Development / Medical Health Services

TÜV SÜD Product Service GmbH

Dr. Juan Martin Carriquiry, CH

Partner & Head MDCP / Medical Devices & Combination Products

Beyond Conception GmbH

Dr. Philippe Auclair, BE

Senior Director of Regulatory Strategy

Abbott Quality & Regulatory

Frank Matzek, DE

VP of Regulatory & Governmental Affairs

BIOTRONIK SE & Co. KG

Dr. Bassil Akra, DE

CEO

QUNIQUE GmbH

Elizabeth Gfoeller, AT

Corporate Director, Regulatory Affairs

MED-EL GmbH

Giacomo Cargnello, NE

BG DI EU MDR Program Head

Philips Medical Systems Nederland B.V.

Kim Trautman, US

Executive Vice President, Medical Device International Services

NSF International

Marcia Orozco, US

Associate Director, MDR & Safety Operations

Alcon

Michel Marboeuf, FR

Sr. Director, RA Corporate

Stryker

Erik Vollebregt, NE

Founder Partner

Axon Lawyers

Stephanie Göbel, DE

Senior Consultant / Medical Devices & Combination Products

Beyond Conception GmbH

Dr. Paul van Geffen, NL

Senior Manager | Regulatory Risk | Life Science & Health Care

Deloitte

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What our
participants
are saying

I enjoyed participating in this medical device event. It allowed me to interact with many enthusiastic professionals caring for the same matter and with the same concerns and similar challenges from all around the world. That was an excellent opportunity to mingle and share scientific excellence from the experts.

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Attendee

Meeting was great, It was a pleasure to meet peers and the organisation was  really good. There is a need for these kind of focused meetings in Europe.

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Attendee

It was very intimate, and we were able to meet with a ton of high-level professionals. We are looking forward to those connections to grow over time as we plan to return next year!

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Attendee