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 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).

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.  

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.  

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.  

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.