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.Read more
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 Online format.
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists and Engineers specialising in:
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 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.
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.
Kim Trautman, former associate director of international affairs at FDA, is an experienced medical device, IVD, and combination product expert with over 30 years of industry and regulatory agency experience.
As managing director and vice president, Kim is an integral part of the MEDIcept executive management team. She provides strategic client consulting services, develops business relationships with new clients, and leads the MEDIcept training immersion program, developing the next generation of medical device consultants.
An expert in global medical device regulations, she wrote and harmonised the current FDA quality system regulation. Kim was also on the FDA authoring committee for 21 CFR Part 4 and FDA combination product GMP guidance documents. In addition, she developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. She is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).
After retiring from FDA, she established an authorised MDSAP auditing organisation and launched a new notified body for EU IVDR/MDR designation. She currently serves on the board of directors at the Regulatory Affairs Professionals Society (RAPS), has been on TC 210 Working Group 1 for ISO 13485 since its 1994 inception, and is a member of the ASTM E55 combination product definitions standard. Kim also serves as the college of engineering vice chair for the industry and professional advisory council at Penn State.
Kim received her master's in biomedical engineering from the University of Virginia and her BSc in molecular cell biology from Penn State.
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).
Stefano is the head of medical devices at confinis ag, a consultancy company specialising in providing advice and services to the medical device, pharmaceutical, biotech, and diagnostic industries.
After graduating in mechanical engineering in 2003, he started his journey into the orthopedic and medical devices covering several roles in the quality and regulatory areas. During those years he built a strong knowledge in CE marking, 510k submissions, international regulatory affairs, process validation including 3D printing, and coatings.
The additive manufacturing processes are among the most used in the custom made and patient matched medical devices. Stefano supported several companies in ensuring compliance to the regulations for these devices through pragmatic approaches and solutions.
Giacomo Cargnello is currently the global quality and regulatory head of the business group Connect & Control Solutions, part of Varex Imaging Corporation, a world leader in X-ray imaging components and medical devices such as tubes, generators, high-voltage connectors, collimators, and more.
He is leading a multi-disciplinary team of 20-plus QA and RA managers and specialists across four different sites (The Netherlands, Philippines, China, and USA) and he is also a member of the business group management team.
He holds 10-plus years of working experience in the medical device industry (Varex, Philips, Baxter, St. Jude Medical/Abbott) covering different medical equipment (implantable pacemaker and defibrillator, hemodialysis equipment, image-guided therapy system, imaging devices for diagnosis - MR, DXR, CT, PET scans - and medical software products) and covering different QA and RA roles with experience in leadership, quality management, and regulatory approval of medical devices, project management, and development.
Giacomo is an expert on international regulations and standards (certified lead auditor), especially EU MDR, ISO 13485, ISO 9001, FDA QSReg, Canadian MDR (SOR-98-282), jPMD Act, IEC 60601, ISO 14971, and ISO 62304.
He holds a master’s degree in biomedical engineering (MSc/MEng) and he participated in several international Q&R conferences as a speaker.
Wiebe Postma is senior consultant and CRO service lead at Qserve Group. Qserve provides QA, RA, CA, and clinical trial services to the medical device and in-vitro diagnostic industries. With 10 years of experience in clinical and regulatory roles in the medical device industry, Wiebe has thorough knowledge of the EU medical device regulations and clinical operations. His goal is to support medical device manufacturers with practical regulatory and clinical strategies towards MDR compliance and CE marking.
Susan Neadle, MS, BS, FAAO is a recognised international combination products and medical device expert with over 35 years of industry experience. Networked, published, and highly active in numerous industry groups with links to many teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others. Susan’s leadership, innovation, and best practices have been recognised with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in R&D, and most recently, as a finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. She is principal consultant and president of Combination Products Consulting Services LLC, applying her extensive leadership, technical skills, and experience to provide hands-on design excellence, international quality and compliance, and regulatory consulting services to the pharmaceutical, biotech, and medical device industries. Among her significant industry affiliations and contributions, she serves as chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, PQRI Product Quality Technical Committee, and teaches a master’s curriculum on combination products at the University of Maryland's Baltimore campus.
Susan was a part of Johnson & Johnson, where her distinguished 26-year-career included integral leadership roles in R&D, quality engineering, design-to-value, and quality systems management, spanning pharmaceuticals, medical devices, and consumer health sectors as well as strategic leadership at J&J corporate level. She served as chair of J&J’s design council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also conceived, developed, and led J&J's cross-sector combination products community of practice. Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet combination products health authority regulations for Janssen, J&J’s pharmaceutical sector.
As partner of our life sciences practice, Fabien Roy focusses his practice at Hogan Lovells on advising clients on European Union and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. Fabien follows the new regulations on medical devices (MDR and IVDR) and the GDPR very closely and regularly advises clients on the requirements applicable to their digital health technologies. With a practice entirely focusing on complex regulatory issues faced by life sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling clients to focus on their business.
Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device clients. Fabien also assists life sciences clients in the preparation, drafting, and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European authorised representative agreements, and distribution agreements.
Within Aidence, Leon Doorn is responsible for the fields of Regulatory, Quality and Information Security. He has implemented the ISO 13485, successfully lead the transfer to compliance with MDR 2017/745 and has obtained the ISO 27001 certificate. He further has worked for a larger medical device manufacturer, and for 7 years as a consultant in quality and regulatory affairs.
Marcus began his career in healthcare market research with Purdie Pascoe in the summer of 2015. This followed on from receiving a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath, which included a 12-month placement working as an analytical scientist for AstraZeneca
The experience and skill he rapidly gained in quantitative research helped him transition and lead the growing PMCF team at Purdie Pascoe for the last three years. He has extensive knowledge in the specific requirements surrounding PMCF surveys, having overseen over 150 surveys for a wide range of medical device manufacturers across a variety of therapy areas. The data from these surveys has been used with EU-MDR submissions to several of the leading notified bodies.
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.
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Feb 20, 2019
Medical Devices: Regulatory and Compliance Summit