Carmen Bellebna is a seasoned professional in the medical device and healthcare technology sector, with a diverse background spanning biotechnology, quality management, and regulatory affairs. She holds multiple advanced degrees, including a Master's in Health and Medical Management, and diplomas in Biotechnology and Industrial Engineering.

Currently, Carmen serves as the Director of Quality & Regulatory Affairs at Deepeye Medical GmbH, where she spearheads the CE marking process for AI-powered medical device software. Her focus is on Software as a Medical Device (SaMD) in the ophthalmology sector, specifically working on treatment planning systems for neovascular Age-related Macular Degeneration (nAMD). Her expertise in implementing quality management systems compliant with MDR 2017/745 and EN ISO 13485 ensures cutting-edge medical software meets rigorous regulatory standards.

With over two decades of experience, Carmen has held key positions at notable organizations such as TÜV SÜD PS GmbH, where she worked as a Lead Auditor for medical devices. Her proficiency extends to auditing quality management systems, assessing technical documentation, and evaluating sterilization processes across various medical device categories.

Anna has more than 5 years experience in Clinical Investigations with Medical Device and over 8 years with Notified Body Certification of Medical Device Manufacturer.

Dr. Miguel Hernandez is a general physician with postgraduate studies in the field of clinical and medical Bioethics. He has been involved in the area of clinical research mainly focused on Medical Devices over the past 12 years, where he has been responsible for pre-market safety reporting and post-market surveillance across Europe, U.S.A., Canada and Japan. His main area of therapeutical expertise include orthopedics, interventional cardiology, CNS, dermatology, rheumatology and women’s health.

He has worked in diverse roles across the industry, including medical device companies and CROs, in roles such as  Safety Officer and Medical Management, Clinical Research Physician, Medical Device Safety Manager, Head of Materiovigilance, and is currently working as Medical Device and Safety Surveillance Lead for UCB,  where is heavily involved in the transition from the Directive 2007/47/EC to the MDR (2017/745) in order to meet regulatory compliance.

Over the last 7 years I have worked in the Medical Device industry, with a primary focus on clinical operations management. I have accumulated a wealth of international experience, executing trials in all regions of the world; Americas (including US), EMEA and APAC (including China). This has given me many opportunities to manage both internal and external partners, and maintain strong multidiciplinary/multicultural relationships. I have also been fortunate to gain experience with managing all stages of clinical trials, notibly with multiple Early Feasibility, First-in-Human and Pivotal studies in the pre-market space, as well as, a global post-market Registry during my career. To date, most of my experience is rooted in the cardiovascular field, having worked on studies for Cardiac Resynchronization Therapy, Mechanical Circulatory Support, Coronary Arterial Bypass Grafts, and Pumonary Heart Valves. In the past years, I have also branched into other indications, such as Vascular Access Grafts (for hemodialysis) and Peripheral Arterial Grafts in the field of vascular surgery.

Dr. Roxana Mittler-Matica is a neurosurgeon with a dual background in medicine and engineering, specializing in spine surgery and the integration of digital health solutions into patient care. She developed digital care pathways and was involved in post-market follow-up studies for medical devices. As an Expert Evaluator for the European Commission, she assessed cutting-edge interdisciplinary research proposals for EU funding, contributing to the advancement of healthcare innovation.

• Biomedical engineer
• 25+ years of medical device industry experience
• 23 years in implantable hearing solutions with Cochlear
• 7 years leading clinical operations in EMEA, overseeing sponsored clinical investigations, controlled market release and post-market clinical follow-up (PMCF) projects
• Focus over past years has been to streamline PMCF data collection at minimum burden to HCPs, users and Cochlear as an organization

Following attainment of a BSc in Biology at the University of Adelaide, Australia, I moved to the Netherlands to continue my education (Master degree and PhD). Started working in Medical Device industry (Cordis Europa NV, the Netherlands) in clinical research in 1991, participating in the multidisciplinary team developing and bringing to the market a hydrodynamic thrombectomy catheter for cardiology and peripheral applications (World-Wide, excl. USA), and permanent and temporary vena cava filters (World-wide including USA). Thereafter worked in academic research in interventional radiology (RadboudUMC Nijmegen) as well simultaneously continuing my work (from 2009 to current -Wellinq) in clinical research in device development projects (Urodynamic catheter & FFR catheter – combining catheter and sensor technology, peripheral angiography catheter and (DCB-)PTCA  devices). Following instigation of the MDR, the main focus was on achieving MDR certification for the marketed legacy devices. All reviewed dossiers were granted CE under MDR.

David Bicknell has over 30 years’ experience in writing about and analysing the technology sector, both from the vendor and the user perspective, both in the UK and the US. His career in technology journalism and analysis has included detailed research into IT projects and he has co-authored a book, ‘Crash’, which explored why and how IT projects go wrong. He has also co-authored a novel on the life of computer pioneer Charles Babbage. Prior to joining Thematic Research, David spent six years editing a GlobalData title exploring the use of technology in the UK public sector. He is currently also studying part-time for an Undergraduate Certificate in the History of Art at the University of Oxford.

Michael has more than 25 years of experience in regulatory affairs and quality assurance acquired within the medical device and clinical research industry across a diverse range of medical device technologies and therapeutic disciplines, and organizations from start-ups to multinationals.

Michael’s expertise spans the complete product lifecycle including clinical research, design, development, technical support, project management, operations and business development in the medical devices sector. His knowledge of the device development process combined with the regulatory requirements, enables him to provide a balanced interpretation of the pre-market and post-market needs and expectations of regulatory authorities.

Frank is a seasoned Director of Program Delivery with over 15 years of international experience within the CRO MedTech environment. Frank leads the EU MedTech Project Management team at Premier Research. As a strategy lead, Frank develops fit-for-purpose proposals, provides strategic oversight on several device programs, and acts as a first level point of contact for executive client contacts. He ensures effective management and coordination across global project teams to support milestone achievements and successful project delivery.

Frank’s background spans the entire device lifecycle, including First-in-Man (FIM), pre- and post-market, and registry studies, with global project coverage across several indications with a main focus on (interventional) cardiology and dermatology.

Before joining Premier Research, Frank held clinical project management roles at Medpace and MediTech Strategic Consultants. He holds an MSc in Physical Activity and Health, specializing in Human Performance and Health Biology from Maastricht University.

Páll Jóhannesson, M.Sc. in Medical Market Access, is the Executive Vice President at Greenlight Guru. Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices

Dr. Andreas Beust is Chief Executive Officer of the Contract Research Organization (CRO) GCP-Service International Ltd. & Co. KG (GCP-Service), which performs national and international clinical trials for medicinal products, medical devices and in-vitro diagnostics. In addition, Andreas is President of the Association of International CROs (AICROS), which is a unique network of small and mid-sized CROs that allow global coverage with local knowledge and a more familial atmosphere and higher flexibility.

Andreas is intimately familiar with requirements of clinical trials on European and international level and has participated in more than 90 trials to date, including five led as trial Sponsor. He gained experience in statistical consulting and trial optimization as Biostatistician. After switching to the role of CEO for GCP-Service International and President of AICROS, his focus shifted to early study consultation from a logistical, regulatory and quality risk management point of view. Connecting small and medium-sized BioTech and Medical Device companies with passionate people and tailored solutions around the globe is the calling he pursues just as much as optimizing trial designs – all in an effort to make clinical trials accessible.

With over 24 years of experience in the regulated medical devices industry, Pradipto is a global technology, innovation, and business leader renowned for driving sustainable growth and value creation. As an R&D leader for nearly a decade, he has successfully led large, complex global teams across multiple regions and disciplines, managing multi-million-euro budgets and delivering disruptive solutions that address unmet customer needs and market opportunities.

In addition to his leadership role at Philips, Pradipto has served as a board member and supervisory board member for Trixell and dpiX. These joint ventures specialize in the innovation, development, and production of X-ray flat panel digital detectors for a variety of applications. He leverages his expertise in strategic partnerships, co-creation, new ventures, and stakeholder management to align with and achieve the strategic goals of these organizations.

Pradipto holds two MBA degrees from top global management institutions and is certified in Six Sigma. He has also received training in Lean, Kaizen, DfX, and other methodologies, ensuring his commitment to quality, efficiency, and operational excellence.

With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field.

In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector.

Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

Stacy is a seasoned project leader with over 15 years of experience in device IDE and biologic trials. She excels in client relationships, guiding them through study design, start-up, and execution. Since 2014, Stacy has specialized in wound care studies, leveraging her expertise to ensure high-quality data. Before joining MCRA, an IQVIA business, she managed wound care and cardiology trials at various CROs. Stacy leads the European Clinical Affairs Division at MCRA, based in London, UK.

Over the last 8 years, I have held various roles across the life sciences industry, focusing primarily on medical imaging. At Medidata, I support imaging data management and event adjudication solutions for clinical trials, as well as our post-commercialization surgical planning tool for medical device companies.

With over 20 years of experience in the life sciences industry, Piet Smet has built a distinguished career spanning clinical operations, CROs, Central Labs, and niche service providers. His deep understanding of the entire medical device and IVD development lifecycle enables him to approach challenges with a truly holistic perspective.

As Clinical Division Head at QbD Group, Piet leads the development of innovative strategies and clinical trials that help bring cutting-edge technologies to market. Recognized for his expertise and leadership, he continues to play a pivotal role in shaping the future of MedTech."

Dr Heike Fischer is a director of Clinical Research at Deloitte and has extensive experience in the fields of clinical research, R&D, QM&RA and market access in the MedTech industry and as a service provider. She built JOTEC from the ground up into a 225-MUSD medical device company that was sold to Artivion Inc. in 2017. Heike has a strong background from idea generation to approval and industrialization of medical devices. Since 2014, Heike has focused on clinical research and developing market access strategies based on a solid value-driven clinical and regulatory strategy. In addition, she supports clients in the end-to-end execution of clinical investigations, the implementation of the ISO 13485 quality management system and product certifications. She understands the value of clinical and vigilance data and the daily challenges faced by small and medium-sized medical technology companies. Heike helps customers create the basis for data-based decision-making and thus make processes more efficient.

Dr. Adnan Shah is a Senior Consultant Medical Writer at Deloitte, with extensive experience in the MedTech industry, notably with class III medical devices/implants in the cardiovascular area and Software-as-Medical Device (SaMD). He has in-depth knowledge and expertise in medical and clinical sciences, international clinical research regulations and guidelines, and European medical device regulations (MDR, IVDR). He supports start-ups & small-to-large size MedTech companies in the preparation of clinical evaluation reports (CERs), clinical investigation reports, scientific publications and other essential documents for regulatory submission. He also supports clients in other areas of product development including clinical investigations as well as quality and risk management systems.

Chems Hachani is a seasoned clinical trial professional with over 10 years of experience in the medtech, pharma, and CRO industries. As the founder of Eclevar Medtech, a tech-enabled CRO, Chems Hachani spearheads innovation in clinical trials with MILO, a cutting-edge platform that accelerates patient identification through GenAI and enhances site effectiveness.

Dr. Nikhil A. Khadabadi is a distinguished medical professional with extensive expertise in orthopaedics, medical devices, and healthcare innovation. As Chief Medical Officer at Eclevar Medtech, he oversees global clinical research initiatives, regulatory strategies, and post-market clinical follow-up (PMCF) activities, contributing significantly to advancing patient safety and medical device innovation. During his tenure at TÜV SÜD, he played a pivotal role as a Clinical Reviewer, evaluating high-risk Class IIa, IIb, and III devices under EU MDD and MDR regulations. His work encompassed critical assessments of prosthetic joint replacements, spinal implants, and dental devices, ensuring compliance with global standards and fostering innovation.

In addition to his contributions to Eclevar Medtech, Dr. Khadabadi leads the clinical team at Milo AI Healthcare, a pioneering platform that leverages artificial intelligence to revolutionize medical decision-making in clinical trials. Under his leadership, Milo AI Healthcare has developed cutting-edge solutions that integrate clinical insights with advanced AI technologies, transforming the healthcare landscape. His dual focus on clinical excellence and technological innovation exemplifies his commitment to improving patient outcomes and driving meaningful progress in the healthcare and medtech sectors.

Frank Maier provides operational leadership and functional oversight of Project Management, specializing in medical device and IVD studies. He has more than 15 years of CRO experience managing international clinical investigations, spanning a wide range of therapeutic areas and study designs. He is an expert in applying regulatory requirements such as ISO 14155, ISO 20916, (EU) MDR 2017/745, (EU) IVDR 2017/746, relevant MDCG guidelines and GDPR. Frank has experience in pre- and post-market clinical investigations including EU-wide submissions and provides effective leadership to teams and excels in strategic planning and creative problem-solving. He participates in inspections and audits, including conducting ISO 14155 audits of customers. Frank holds a Specialized Registered Nursing degree in intensive care.