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.

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.

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.