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 the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.

Rana Chalhoub is an experienced Regulatory Affairs Professional with a demonstrated history of working in leading multinational medical devices companies such as Medtronic, Johnson & Johnson and Hospira Pfizer. During her career, Rana has managed to take over regulatory roles of increased responsibilities with an extended area coverage where she has built extensive knowledge of the regulations across MEA region.

Rana holds a Medical Laboratory Sciences degree along with a Regulatory Affairs Certification (RAC) from RAPS, and a certificate in “Regulation: Theory, Strategy & Practice” from London School of
Economics & Political Sciences (LSE). In her current role as Regulatory Affairs Director at Mecomed, Rana is responsible for managing Regulatory Affairs-related responsibilities in MECOMED, the Medical Technology Association in Middle East and Africa, and works closely with the different MedTech stakeholders such as Ministry of Health officials and Regulatory agencies to advance the Medical Technology Regulations in the region.

Rana is also co-chairing the GMTA (Global Medical Technology Alliance) Africa Working Group, and has been actively involved in the MDRC (Medical Device Regulatory Convergence) program for Africa.

Rana has also been engaged as a speaker and subject matter expert in several international and regional forums in Europe, Africa, Asia Pacific and the Middle East, on several topics such as Good regulatory practices, Reliance principles and Regulatory environment in MEA region.

Dr. Lyudmila Dashdamirov is a highly experienced regulatory expert with over 15 years in the life sciences and medical device sectors.
Across different companies Lyudmila has successfully led complex product registrations and regulatory process optimisation across diverse markets in Europe, Russia, and the Middle East.

Qualified to a master’s degree in biotechnology, based in Geneva-Lausanne area in Switzerland and working as a Vice President Regulatory Affairs EMEACLA (Europe, Middle East, Africa, Latin America, and Canada). In my current role I am directing and influencing regulatory strategies and guide the company through multiple regulatory changes and dynamics, including investment into capabilities. I also have a special focus on regulatory and clinical pathways for marketing authorization and patient access, that also includes the risk benefit approach in clinical evidence and Real World Evidence especially for therapies that address unmet medical needs.
Prior to joining Edwards I was a Sr. Director Regulatory Affairs EMEA at Medtronic, headed up Regulatory Affairs at Colgate-Palmolive Europe Sarl. in Basel, Switzerland. I have previously held the management positions in Research and Development, Manufacturing Process Management and Quality Assurance at Unilever company. And have also worked as an independent consultant to the cosmetic industry and for alternative toxicological
methods.

Dr. Andrew Gibson is an experienced medical device regulatory affairs and quality management consultant. He has a background in microbiology, chemical characterization, and biotechnology.

Working in Germany, Ireland and Canada, Andrew has had significant experience with EU, US, Canadian and other global regulations. Within these markets he has developed a unique skillset with a variety of medical devices from class I to class III.

He has led project teams to identify gaps and update documentation helping manufacturers address the requirements of EU medical device regulation (MDR). He has specific expertise in clinical evaluation, post-market surveillance and technical documentation. For U.S. markets, he completed several successfully cleared 510(k) premarket notifications and PMA supplements.

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.

Ágnes is medical doctor, working at CE Certiso (NB 2409) as an internal clinician since 2011. As the Clinical Lead of the notified body she has performed hundreds of CER, PMS, PMCF assessments. She represents CE Certiso in the NBCG-Med and Team-NB. Ágnes has in-depth knowledge of the medical device regulation and guidance documents.

Amelia Hufford, PhD is the senior vice-president of Clinical and Regulatory Science and co-founder of 3Aware, a clinical data solution serving the real-world data needs of healthcare and medical device manufacturers. Dr. Hufford has 20 years of experience in scientific and clinical research, including over 10 years within the MedTech industry. She has led teams in regulatory and clinical affairs and has guided the approval and continued market access of many medical products. Using information buried within electronic medical records, she and 3Aware have pioneered methods of uncovering key elements of patient outcomes following treatment with devices.

Ms. Irene Lu has been working in Qualtech since 2012 responsible for product evaluation, consultancy and clinical trial strategies.
She is an expert when it comes to medical device regulations and with regards to assisting and providing advice to manufacturers on how to enter Asia-Pacific markets at the earliest time.

Steven Reichen is a founding member of FLINN, where he has been instrumental in guiding some of the world’s leading medical device manufacturers — including Med-El, Dentsply Sirona, pfm medical, Camlog, and Oculus — through successful transitions to AI-powered regulatory operations. His work focuses on replacing outdated, manual compliance tasks with context-aware automation tailored to the realities of MDR and IVDR.
Steven specializes in helping regulatory and vigilance teams deploy AI tools that don’t just search — but understand — the complex, shifting requirements across literature evaluation, safety monitoring, and global regulatory surveillance. His strength lies in translating real-world regulatory workflows into intelligent systems that reduce risk, increase speed, and scale across geographies.
Having led market expansions into France, the UK, and the United States, Steven brings a pragmatic, field-tested perspective on what it takes to operationalize digital transformation in diverse regulatory environments. Whether it’s navigating FDA-specific expectations or aligning with European notified bodies, he knows how to bridge AI capabilities with compliance constraints — and make it stick.

Biography available soon

Marcus joined Purdie Pascoe in 2015, with a First Class MSci in Natural Sciences (Chemistry with Pharmacology) from the University of Bath.
Since joining he has rapidly gained experience and skill in quantitative research and has led, and grown, the PMCF team at Purdie Pascoe for the last four years, who provide PMCF survey solutions to the medical device industry to ensure EU-MDR compliance.
He has extensive knowledge in the specific requirements surrounding PMCF surveys, having overseen over 400 surveys for several of the leading 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 and high-quality patient specific surveys.

Tibor Zechmeister is currently the Head of Regulatory and Quality at FLINN, an innovative SaaS company delivering AI-powered automation software for regulatory compliance.
With nearly 15 years in the medical device industry, Tibor brings extensive experience as an entrepreneur, auditor, consultant, and thought leader.
After earning his degree in biomedical engineering, Tibor started his entrepreneurial journey by founding his first medical device company. Since then, he has successfully built, co-founded, or held key leadership roles in four medical device businesses—two dedicated to creating advanced medical devices, and two focused on developing software solutions aimed at simplifying and automating regulatory processes.
As a lead auditor for a notified body, Tibor has conducted numerous audits, giving him a deep understanding of the regulatory and quality management challenges faced by medical device manufacturers. Recognizing the inefficiencies and repetitive tasks that burden professionals in the field, he has dedicated his career to optimizing these processes through automation and advanced technologies.
Tibor’s expertise extends beyond business leadership and auditing; he has consulted extensively with medical device companies, helping them streamline compliance activities and enhance operational efficiency. His commitment to sharing knowledge is evident through his co-authorship of multiple publications and expert literature within the industry.
At his core, Tibor is driven by the belief that medical innovation should be both accessible and safe. He continues to advocate for smarter, AI-driven regulatory solutions that improve compliance while allowing healthcare professionals to focus on meaningful, impactful work.