A specialist histopathology lab built around one quality system.

Prof. Dr. Mike Barbeck founded BerlinAnalytix in 2018 and is a leading expert in biomaterial science and the development of new medical devices, with more than 20 years of experience across academia and industry.

He studied human medicine at Goethe-Universität Frankfurt and Johannes Gutenberg-Universität Mainz, graduating with a focus on biomaterial discovery and development. He earned his doctorate at Mainz in 2014. His early research career spanned the Institute of Pathology at the University Medical Center Mainz; the Clinic for Oral, Maxillofacial and Plastic Facial Surgery at the University Hospital Frankfurt, where he led an in-vivo research group on the inflammatory tissue response to biomaterials; and the role of Head of Research & Development at botiss biomaterials in Berlin, before founding BerlinAnalytix.

Using histopathological and histomorphometric methods, he developed a standardised, computational system for evaluating the tissue reaction to biomaterials, focusing on macrophages and multinucleated giant cells and the link between inflammation and tissue regeneration. He has since published over 150 peer-reviewed articles across biocompatibility, foreign body response and biomaterial characterisation, and leads a research group specialising in the biology of biomaterials at the Clinic and Policlinic for Dermatology, Venereology, and Allergology of the University Medical Center Rostock.

He is also a guest lecturer in Biomaterial Science at several university programmes in Germany and abroad.

A graduate of the Department of Human Medicine at Semmelweis University, Dr. med. univ. James Bielenstein is currently pursuing his PhD at the University of Rostock, with a focus on in vivo biomaterial integration and the immune responses associated with xenogeneic and synthetic tissue implantation.

Following his graduation in 2022, he gained clinical experience in traumatology and orthopaedics as a resident surgeon in Switzerland, and worked in the healthtech private-equity sector before joining BerlinAnalytix. He has served as scientific advisor to Remi Health since the company's founding.

At BerlinAnalytix, Dr. Bielenstein holds Test Facility Management (Leiter der Prüfeinrichtung) responsibility for the GLP-compliant operation of the laboratory, its personnel, infrastructure and quality systems, ensuring the scientific quality of every study conducted. He works directly with clients to optimise implantation study design, outcome analysis and regulatory reporting, ensuring studies are structured to answer the questions that matter to submission. A background in software development underpins the digital pathology and histomorphometry infrastructure that distinguishes the BerlinAnalytix workflow.

Dr. Burckhardt holds a doctorate in biocompatibility evaluation of biomaterials for bone and soft tissue regeneration, building on a Master's in Biology, and has specialised in histological and immunohistochemical tissue analysis. During a two-year pathology internship at the BG Klinikum Unfallkrankenhaus Berlin (ukb), she gained extensive experience in tissue processing, histopathology and immunohistochemical staining, including the investigation of inflammatory processes in human tissue samples with particular attention to the differentiation of M1 and M2 macrophage phenotypes in various pathological conditions.

As Scientific Investigator at BerlinAnalytix since October 2022, Dr. Burckhardt leads the histological assessment of medical devices and biomaterials in accordance with ISO 10993-6 and related international standards. Her expertise covers tissue–implant integration, inflammatory tissue responses and regenerative processes in both soft and hard tissue implantation models, with deep specialisation in semi-quantitative histopathological scoring under ISO 10993-6. She supports clients in the interpretation of complex biocompatibility data and translates histological findings into regulatory submissions.

Her doctoral research evaluated modified bone substitute materials and barrier membranes, and compared subcutaneous and calvarial implantation models for the assessment of novel bone regeneration materials. This scientific background allows her to combine detailed histopathological analysis with a working understanding of biomaterial development and regulatory biocompatibility requirements, making her a direct interlocutor for sponsors as well as a histopathologist.

Andrea Keding has worked in quality management within medical and laboratory environments for over a decade, with deep practical experience in DAkkS accreditation procedures, internal auditing, and the maintenance of accredited quality management systems. She holds an M.Sc. in Business Psychology with a focus on personnel and organisational development (BSP Business School Berlin), a state-recognised qualification as Medical-Technical Laboratory Assistant (MTLA) from Ernst-Moritz-Arndt-Universität Greifswald, and a certificate in Medical Quality Management from the Bayerische Landesärztekammer.

As Quality Manager (Qualitätsmanagementbeauftragte) at BerlinAnalytix, Ms. Keding maintains the laboratory's quality management system, prepares and accompanies DAkkS accreditation procedures, conducts internal audits, and serves as the central point of contact for management and specialist staff on all quality matters. She is responsible for ensuring that BerlinAnalytix's ISO/IEC 17025 accreditation and GLP certification are upheld in day-to-day operations.

Before joining BerlinAnalytix, she spent over twelve years as Sanitätsfeldwebel in the medical service of the German Federal Armed Forces (Bundeswehr), including five years as deputy quality management officer, and subsequently served as Deputy Quality Management Officer at Bundeswehrkrankenhaus Berlin, where she maintained the QMS under DIN EN ISO 15189 and supported the institution's DAkkS accreditation. This combination of frontline laboratory experience, formal QM training, and a Business Psychology background gives her a working understanding of both the technical and organisational dimensions of quality systems.