Dr. Stephan Theinert is Head of Clinical Affairs and Development at EyeSense GmbH, a medical device developer based near Frankfurt, Germany, where he has led clinical and regulatory strategy since 2009, reporting directly to the CEO. With nearly 20 years of experience in clinical research across pre-clinical and Phase I–III trials — including first-in-human studies — he brings deep expertise in clinical pharmacology, medical devices (ophthalmology and diabetes), regulatory affairs, and design control.
He holds a PhD in Immunology from Humboldt University in Berlin and began his career in academic tumor immunology and infectious disease research before moving into international CRO leadership roles at PAREXEL and Momentum Pharma Services. Dr. Theinert has led multimillion-euro clinical programs, supported regulatory submissions for CE marking and ISO 13485 certification, and managed clinical trials in compliance with ICH-GCP and ISO 14155 under MPA, MDD/MDR.
Known for his strong project leadership and communication skills, he combines scientific depth with operational excellence across business development, clinical affairs, biocompatibility, risk management, usability/human factor, and regulatory strategy.
The AO Foundation is a surgeon-led, not-for-profit organization advancing patient care in trauma and musculoskeletal disorders through education, research, and innovation, powered by a global network of more than 500,000 surgeons.
With a PhD, 13 years of experience in clinical research, and an Executive MBA, Katrin Simioni combines scientific rigor with operational leadership as Deputy Head of Clinical Operations at the AO Foundation. AO Clinical Evidence comprises more than 30 experts across key clinical research functions, working with surgeons and industry partners to deliver medical device studies as well as large, international, multicenter observational research (cohorts and registries). This work focuses on understanding real-world treatments and outcomes, translating evidence into practical recommendations, and adopting evolving technologies to enable efficient, high-quality global data collection.
Maike Hiller is a Clinical Development Scientist at Philips with a focus on PMCF studies in the business unit Hospital Patient Monitoring. In her career in the MedTech industry over the past 20 years, she gained extensive experience from various positions in Product Management and Marketing, User Training, Business Development and Clinical Research. Her in-depth product knowledge reaches from class I to class III products in the clinical domain of Acute Care and spans product applications in very developed but also developing markets. In her Clinical Development role, she focusses on real world evidence generation in mixed method Post-Market-Clinical-Follow-up (PMCF) activities. Besides meeting regulatory EUMDR requirements and focusing on patient safety and closed loop product improvement, efficiency, scalability and cost-effectiveness are key aspects in her study designs. In this rather new domain of PMCF, she values knowledge and best practice sharing through different MedTech associations work groups and maintaining also an active dialogue with the different stakeholders on opportunities and limitations in this regulatory field.
I have spent over 25 years in the medical device industry focusing on two core challenges: identifying the essential clinical evidence needed for an innovative device and strategizing the most efficient way to acquire it. My work is driven by the conviction that innovation thrives when we eliminate excess overhead and are willing to cross geographic borders to get the evidence we need.
Dr. Ulrich Nitsche, M.D./Ph.D., is Global Director and Head of the Clinical Centre of Excellence at the notified bodies TÜV SÜD NB0123 and TÜV SÜD NB2443. In addition to his work as an internal clinician, Ulrich Nitsche is member of the German Institute for Standardisation (DIN-Normenausschuss) in the Clinical Trials / Clinical Evaluation Working Group. In addition, he is member of the Ethics Committee of the Technical University of Munich and of the Specialised Ethics Committee for Special Procedures of the BfArM. Ulrich Nitsche is a specialist in visceral surgery and a senior emergency physician.
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 Clinical 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.
