MedDev Day - Relatori

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. 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 in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. 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), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 20 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures at University of Applied Sciences (IMC Krems) and speaks regularly at international conferences.

A biomedical engineer with a PhD in Biophysics, Alessandra Basilisco has been working in the medical device sector since 2002. She has extensive experience in European medical device regulation, market surveillance, conformity assessment, and the designation of Notified Bodies. She currently coordinates medical device market surveillance activities within Office 3 of the Directorate-General for Medical Devices and Pharmaceuticals at the Italian Ministry of Health. She represents Italy in the Working Party on Pharmaceuticals and Medical Devices of the Council of the European Union and in the Medical Device Coordination Group (MDCG), and serves as Co-Chair of the MDCG Market Surveillance Working Group at the European Commission.

She has contributed to European activities supporting the implementation of Regulations (EU) 2017/745 and 2017/746, participating in working groups on market surveillance, borderline devices, EMDN nomenclature, shortage management, and Notified Bodies, as well as in numerous European Joint Assessments. She also represents Italy in strategic working groups at the European Medicines Agency (EMA).

Her expertise combines engineering, scientific, and regulatory perspectives, with a particular focus on European medical device governance, Health Technology Assessment (HTA), post-market surveillance, and the management of technical and administrative procedures. She also serves as Scientific Lead for institutional projects in the fields of medical devices and technological innovation. She lectures in university courses and postgraduate Master’s programmes on regulatory sciences, HTA, and medical device governance, and regularly speaks at national and international conferences. Her professional contributions have been formally recognised by the Italian Ministry of Health, and she is the author of scientific publications and technical-regulatory contributions in the fields of medical devices and HTA.

Over 30 years of experience in Class II and Class III medical devices, including active implantable products. Recognized expert with a strong focus on post-market surveillance, leveraging data-driven insights to continuously improve product safety and performance. International experience across global teams and markets. Specialties include Quality Assurance, Post-Market Surveillance, and Quality Engineering supporting both R&D and manufacturing, with deep expertise in the EU Medical Device Regulation (MDR).

Marika Chrápavá is a Medical Advisor and Regulatory Affairs Manager at the Institute of Biostatistics and Analyses. With over 20 years of profound expertise in the pharmaceutical industry, her work focuses on designing innovative clinical trials and research projects for medicinal products and medical devices including defining regulatory strategies. Marika´s leadership was instrumental as the Head of the Clinical Projects Department, managing a broad spectrum of clinical research projects mostly international, of various designs, including Real-World Evidence (RWE) data mining and its application in clinical research. Recognized for her contribution to the medical device field with a bronze award at the International Innovation Fair in Stockholm, her career is a testament to her commitment to advancing medical science and regulatory excellence.

Basira Evard, PhD, leads the Clinical Science team at Teleflex and brings over a decade of experience in the medical device industry, specializing in clinical evaluation and clinical/regulatory strategy for cardiovascular technologies. She is responsible for developing clinical evidence strategies for Class II and III devices, with a strong focus on EU MDR requirements—including clinical evaluation reports (CERs), post-market clinical follow-up (PMCF), and benefit–risk assessment—while translating evolving regulatory expectations into practical and efficient evidence generation strategies that support both compliance and innovation.

BD in Biology with a focus on physiopathology, PhD on chemical and mechanical properties of materials used in healthcare sector and their correlation with surgical site infections of the operating theatres and more than 20 years of extensive experience in university and medical device, pharma and healthcare Organizations related to scientific research, R&D, production, validation, risk evaluation, testing and conformity assessment activities. From 2014 I’m the Director of Medical Device Business Unit in Kiwa Cermet Italia, an International Company providing globally Testing, Inspection and Certification services, with the responsibility to develop and guarantee the correctness of the medical certification business of the Notified Body 0476, managing its related P&L and leading a team of more than 40 experts. Moreover, as a qualified auditor and product assessor I also carried out conformity assessment activities especially on non-active substances-based and implantable device. As a member of Team NB, I am also involved in technical working groups and task forces with the aim to laid down position papers and to provide comments requested by MDCG during the drafting of the guidelines.

Technical and Regulatory Support Manager TÜV SÜD for Europe; Lead Auditor and Technical Documentation Assessor for non active medical devices.Dr. Carlo Gherardi holds a MSc in chemistry. He joined TÜV Italia (TÜV SÜD Italian subsidiary) in 2004 as Lead Auditor and Technical Documentation Assessor for non active medical devices. Previously, he had 10 years of professional experience in the design and development and quality assurance of sterile non active medical devices, in the area of transfusion, nutrition and extracorporeal blood circulation in the medical devices industry.Carlo is actively driving MDR EU Regulation 2017/745 conformity assessment activities for non active medical devices customers in Italy and internationally, while he’s managing the European team for handling onboarding of new clients in the medical device and IVD area.

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Richard Houlihan is the leading authority on EUDAMED. Richard is an international speaker and guest lecturer at universities on EUDAMED.
His experience in running the European Commission’s IT teams, which developed EUDAMED, has provided him with unrivalled insights into how EUDAMED impacts the MedTech industry. This EUDAMED experience, combined with his 30 years of IT expertise, gives him and his company a significant advantage when helping companies prepare for Vigilance and Device submissions to EUDAMED, FDA GUDID, SwissDaMed, AusUDID, and other regulatory submissions. Other services include EUDAMED Vigilance submissions, EUDAMED Monitoring (PRRCs), consultancy, training, and project management. To date, Richard and his team have trained over a thousand people on EUDAMED, provided consultancy and support to numerous companies, and uploaded thousands of UDI DIs to EUDAMED.

Graduated in Pharmacy with a specialization in Hospital Pharmacy, she has developed broad professional experience across the pharmaceutical sector and in vitro diagnostic medical devices (IVDs).
Her career has included roles in both community and hospital pharmacy, where she gained expertise in patient care, pharmaceutical services, medication and medical device management, and clinical support activities. During the COVID-19 pandemic, she contributed to hospital pharmacy operations and to the EOS mission at Pratica di Mare Military Airport, supporting the technical, regulatory, and logistical management of COVID-19 vaccines and medicines.
She has also gained significant experience within the Competent Authority for in vitro diagnostic medical devices, working on regulatory and market surveillance activities under the European regulatory framework. Her work has focused on the designation and oversight of Notified Bodies, market surveillance, and vigilance activities, contributing to the monitoring of the safety, performance, and compliance of IVDs placed on the market and used in healthcare settings.

Dr. Tonia Jeiter is a board-certified gastrointestinal surgeon with ten years of clinical experience at a German university hospital. She joined TÜV SÜD Product Service GmbH in 2018, progressing from clinical reviewer to team lead and global clinical data trainer, where she managed a multidisciplinary team of clinical evaluations specialists and provided expert training on EU MDR compliance on a global capacity. Dr. Jeiter also served as a senior clinical panelist and trainer for Team NB. In 2024, she became Senior Clinical Consultant at Akra Team GmbH, advising manufacturers on clinical evaluation and conformity under EU MDR. Currently, she is Senior Manager, Clinical Evaluation and Lifecycle Management at Alcon, driving clinical regulatory strategies for new product development portfolio and providing comprehensive, cross-functional oversight and guidance on all aspects of clinical evaluation and clinical lifecycle management.

Giulia Magri graduated in Industrial Pharmacy in 2015 from the University of Milan (ITA) and earned a European PhD in Pharmaceutical Science in collaboration with the University of Bath (UK) in 2019. Her research focused on polymeric micro- and nanoparticles stable to sterilization for prologued drug release and on in vitro models simulating healthy and pathological joint conditions for anti-inflammatory drug applications. In 2018 she joined the R&D department of ab medica, working on biocompatible polymers for drug delivery and regenerative medicine. Since 2021, she has been with Confindustria Dispositivi Medici, the Italian trade association representing medical technology industry, where she is now Director of Quality & Regulatory Affairs office.

Nunung Nur Rahmah, M.D., PhD, is a prominent medical and regulatory professional specializing in clinical evaluation for medical devices. She currently serves as the Head of Internal Clinical Team at DEKRA Product Testing & Certification. She has an extensive background in clinical practice, clinical trial safety and neuroscience research totaling more than 20 years of experience. She frequently presents at international medical technology and regulatory conferences. She is also actively involved with Team-NB (The European Association of Medical Devices Notified Bodies), providing training to manufacturers on clinical evaluation strategies and regulatory success.

Maddalena Pinsi is a senior regulatory leader with over 15 years of experience across the medical device industry and Notified Body sectors. She holds a Master’s Degree in Medical Biotechnology and has built her career at the intersection of science, regulation, and strategic leadership.
She began her career in industry, where she led global regulatory strategies, secured approvals in multiple jurisdictions, and translated complex regulatory requirements into clear product and project pathways.
Since joining BSI, Maddalena has advanced into strategic leadership roles and now serves as Head of the Notified Body. She provides regulatory, strategic, and operational oversight for BSI’s EU Notified Body activities, ensuring alignment with legislative, designation, and accreditation requirements. Her work spans strategy, policy development, governance, performance oversight, and stakeholder engagement.
Maddalena partners closely with senior leadership to drive regulatory excellence, strengthen system robustness, and reinforce BSI’s position as a trusted, high performing Notified Body.

Florian Schwarze is Senior Clinical Research Manager in the clinical research team for cochlear implants at MED-EL. Florian has 17 years of experience in the medical device field in the clinical research area with AIMD and class III devices. In his team he is responsible for designing and conducting pre- and post-market clinical investigations, registries, surveys, and for supporting the clinical evaluations team. Florian is based at MED-EL global headquarters, in Innsbruck, Austria.

Nebojsa Serafimovic is Head of Unit for Clinical Investigations and Performance Studies at the Austrian Federal Office for Safety in Health Care (AGES/BASG).
In this role, he is responsible for the regulatory oversight and assessment of clinical investigations with medical devices and performance studies with in vitro diagnostics and plays a key role in shaping both national and European regulatory processes related to the implementation of the MDR and IVDR. His work includes active involvement in EU-level coordination and harmonisation initiatives, notably as Lead of the EUDAMED Oversight CA Board (CIPS), Co-Lead of the work package on coordinated assessment under MDR Article 78, and Co-Lead in one of the COMBINE projects, focusing on the interface between clinical investigations of medical devices/IVDs and medicinal products.

Previously, he worked at Philips Austria in medical device engineering and at the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM Vienna.

Nebojsa is an active member of the Clinical Investigation and Evaluation Working Group (CIEPSE) and contributes to several European task forces aimed at further developing and harmonising the regulatory framework for clinical investigations in Europe.

Marcus joined Purdie Pascoe in 2015, with a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath.
After nearly 5 years within the Primary Market Research team, he leveraged his skills in quantitative research and took on leadership of the Post Market Survey team at Purdie Pascoe in 2019. The team is now 15+ people strong, and provide Post Market Survey solutions to the medical device industry to ensure global regulatory compliance, through PMCF, PMPF and wider RWD data collection.
He has extensive knowledge in the specific requirements surrounding Post Market surveys, having overseen over 500 surveys for a wide range of global Medical Device manufacturers across a variety device types.  These surveys have been approved by several of the leading Notified Bodies and consist of both end user general surveys (Level 8) and high-quality case specific surveys (Level 4).