Geschäftsführung
Markus Gerhart has been supporting the Johner Institut since almost the beginning. As one of the first employees, he was and is allowed to help to design the processes and values of the Johner Institut.
Markus Gerhart, M.Sc.
Regulatorische Rollen & Virtual Manufacturing (Johner Medical)
Lesley Plön is a consultant for the roles of an external Quality Managemener and PRRC. With a Master's degree in Quality Development and Management in Healthcare, she has gained professional experience both as a Quality Management Officer in a hospital and as a project director for medical technology. She is now particularly looking forward to providing support and consultation regarding technical documentation for medical device manufacturers.
Lesley Plön, M.Sc.
Dimitrios Kaloulis supports customers in outsourcing regulatory roles: Management Representative according to ISO 13485, Authorized Representative and Responsible Person according to MDR. He accompanies customers through the certification process and conducts audits (1st and 2nd party) in accordance with ISO 9001, ISO 13485, MDR, MDSAP. His areas of expertise include the creation of technical documentation and the development of QM systems. With a degree in mechanical engineering and an M.Sc. in biomedical engineering, as well as experience in industry and research, he has extensive expertise in supporting our customer projects.
Dimitrios-Karolos Kaloulis, M.Sc.
Margarita is Lead Link of the Regulatory Roles team at Johner Medical. With over 15 years of experience in regulatory affairs, she supports clients as a qualified MDSAP auditor, external QM representative according to ISO 13485 (5.5.2) and external responsible person according to Art. 15 MDR/IVDR. She and her team act as authorised representatives in the EU, Switzerland, the UK and as US agents in the USA. Their in-depth expertise ensures compliance with local and international regulations.
Margarita Rozhdestvenskaya
Dr Bernhard Gerstenecker, who holds a doctorate in microbiology, looks back on a career in the medical device industry with a focus on IVD systems. Over the course of 25 years, he developed immunochemical reagents and test procedures, established QM systems and worked in regulatory affairs. He spent a further 10 years as Quality and Regulatory Affairs Manager in the IVD device industry. He has been working permanently at Johner Medical since December 2021, supporting customers in regulatory roles (external QMB, PCCR), eQMS solutions, technical documentation review and internal audits.
Bernhard Gerstenecker, Dr.
Team Clinical and Safety Affairs
Susanne Golombek supports our clients as a consultant for clinical evaluation and clinical trials. After completing her master's degree in molecular biotechnology, she worked in preclinical cancer research. She then spent several years working as a clinical trial monitor and developed her skills in the field of regulatory affairs for medical devices. There, she supported researchers in compiling technical documentation and implementing new developments in clinical trials. Since 2023, she has been supporting our clients with her interdisciplinary expertise in the field of clinical affairs.
Susanne Golombek, M.Sc.
Dr Anja Kuhnert is an experienced expert in regulatory and quality affairs with over ten years of experience in bringing medical devices to market. She is well versed in the implementation of QM systems according to ISO 13485 and clinical evaluations according to MDR (EU 2017/745). She has developed and coordinated approval strategies for medical devices in various risk classes. Her structured, results-oriented approach and scientific curiosity make her an accomplished consultant with extensive experience in clinical evaluation and post-market surveillance.
Anja Kuhnert, Dr.
Tanja Domke supports our customers in regarding clinical evalutation and biocompatibility. After completing her PhD in stem cell research at the University of Dundee, Tanja worked in the field of Clinical Management. She then moved on to the area of clinical benefit assessment and market access of pharmaceutical prodcuts. Since 2023, she has been supporting the Johner Institute with her cross-divisional expertise and scientific background.
Tanja Domke, Dr.
Dr. Johannes Goldmann received his doctorate in pharmaceutical biology. He worked for six years in stem cell research at the Institute for Transfusion Medicine and Immunohematology in Frankfurt am Main. There he was study coordinator for several clinical phase III studies. He therefore knows the challenges of developing medical products from his own experience. He also worked in the pharmaceutical sector for a Berlin pharmaceutical company for six years. His focus is on advising on clinical studies, study design and activities related to the PMCF
Johannes Goldmann, Dr.
Sarah Gruber is a biotechnology engineer and has been working for many years in the field of product safety with core competencies in biocompatibility and toxicology, and cleaning validation, sterilization, and reprocessing of reusable medical devices. As an expert in biological safety of medical devices, she supports our clients with her experience in strategic planning of necessary tests, organization and supervision of laboratory tests up to risk-based toxicological evaluation of the results from development to approval of medical devices.
Sarah Gruber
Lea Wettlaufer supports our customers in the preparation of clinical evaluations and post-market surveillance of medical devices. Her focus is on clinical strategies in accordance with MDR requirements. As a certified Clinical Research Associate, she is familiar with the interaction between clinical trials and evaluations. She provides support for post-market activities, particularly clinical follow-up. As a lecturer for seminars, workshops and our Medical Device Days, she is very familiar with the challenges our customers face in the area of clinical evaluation and PMS/PMCF.
Lea Wettlaufer, M.Sc.
Dr. Bettina Martin, a distinguished neuroimmunologist, has been a key figure in the leadership team of the Johner Institute since 2019. She has led multiple teams and departments, including Clinical Affairs and, as an interim manager, the entire consulting division. Since 2024, she has been heading the Clinical and Safety Affairs department. Her core competencies include strategic planning, business development in the field of clinical evaluation, digitization, and cross-departmental team leadership.
Bettina Martin, Dr.
Nadine Jurrmann has a PhD in biology and was employed by a medical device manufacturer for over six years. Her responsibilities at that time included the preparation of clinical evaluations and the planning, implementation and analysis of PMCF studies. Since 2019, she has been supporting our customers with strategic consulting on clinical evaluation as well as the documentation of PMS and PMCF activities in accordance with the MDR.
Nadine Jurrmann, Dr.
Team DAP (Digital Approval Platform)
Marina Radcke is responsible for the content of the software solution DAP-eTD (Digital Approval Platform) as part of our Realtime Compliance System (RCS). With her background as a computer scientist and her professional experience, she brings expertise in the management of software projects as part of medical devices. She has previously worked in various roles as Managing Partner of a medical technology start-up, as a quality manager and as a project manager for software development projects in the fields of vascular surgery and radiotherapy.
Marina Radcke
Lisa Wittmayer is responsible for the Digital Approval Platform (DAP) and the digital quality management system. She studied biomedical engineering and medical physics and spent time abroad at the University of Melbourne and Harvard Medical School. After her studies, she initially worked as a research assistant and project manager at the University of Heidelberg. As a University spin-off, she founded a medical technology startup in 2018 and took over as CEO before joining Johner Medical in March 2022 and then Johner Institut in July 2023.
Lisa Wittmayer
Team DPMS (Digital Post Market Services)
Michael Neumann has a degree in computer science. He has already worked in several industries and positions and supports software development as an AI expert.
Michael Neumann
Catalina Paez Garza completed her Bachelor's degree in Chemical Biology at KIT and her Master's degree in Bioeconomy at the University of Hohenheim. It was there that she discovered her interest and motivation for medical and pharmacological products. After her studies, she supports the Johner Institute in the field of Digital Solutions, especially in the area of Regulatory Radar.
Catalina Paez Garza
Leon Holub has been supporting the Johner Institute in the development of our software products since the beginning of 2023, first as a developer and then as Product Owner of the Regulatory Radar, contributing his more than ten years of experience in the design and implementation of innovative applications. In his spare time, Leon enjoys sport climbing and road cycling.
Leon Holub
Colin Weidlich graduated in biology with a focus on disease biology. After graduating from the University of Konstanz, he is now full of energy to support the Johner Institute in the area of post market radar. His goal is to provide efficient and precise support to our customers, thereby achieving a sustainable positive impact for them and their products.
Colin Weidlich, M.Sc.
After his studies, Bernd Huber worked for several years in the software industry on the development of online shops and online survey platforms.
With his fascination and passion for web applications, he supports the Digital Post Market Services team and contributes his expertise as a full-stack software developer/architect. Together with the team, he works on the continuous development of the SaaS solution(s).
Bernd Huber, M.Sc.
Andrea Seeck is a Dr.-Ing. in medical technology and has many years of experience in the field of Clinical & Regulatory Affairs. She joined the Johner Institute in April 2017 and is now Head of Digital Solutions. She firmly believes that the best digital solutions come from a deep understanding of regulatory challenges combined with cutting-edge technological know-how. Together with her team, she successfully translates complex legal frameworks into user-friendly digital tools, significantly reducing the compliance burden for our clients.
Andrea Seeck, Dr.-Ing.
Franziska Reichel, a microbiologist, worked in infection biology during her thesis. There, she explored the pathogen Staphylococcus aureus and new antibacterial substances. After completing her studies in Tübingen, she now supports the Johner Institute in the area of Regulatory and Post Market Radar.
Franziska Reichel, M.Sc.
Team E-Learning/Auditgarant
After completing his studies in business informatics and a master's degree in computer science with a thesis entitled ‘Identification and design of software to support post-market surveillance of medical devices,’ he entered the industry. He has been with the institute since 2018, initially as a consultant for the development and regulatory compliance of QM systems and technical documentation. Since August 2021, he has been Product Owner in the e-Learning team and supports the content and technical development of e-learning products using product discovery methods.
Sebastian Lettau, M.Sc.
Team Entwicklung und Infrastruktur
Since completing his master's degree in computer science at Trier University of Applied Sciences Andreas Hämmerl has been involved in the development of software in the medical environment. Before and during his studies he worked in web development for many years. He is now continuing his passion for web technologies as a software developer for the Johner Institute's various web platforms.
Andreas Hämmerl, M.C.Sc.
Team Human Resources
Nicole Waldraff began her training in the public sector, where she also trained as a business administrator. In HR, she is responsible for personnel development, occupational health management and trainees.
At the Johner Institut, she is responsible for HR management and is the point of contact for employees, managers and the management. She also supports the recruitment process and the induction of our new colleagues and ensures employee satisfaction and retention. She particularly appreciates the exchange with different personalities.
Nicole Waldraff
Isabelle Pflug studied international business administration with a focus on human resource management and the Francophone world. After two semesters abroad in London and Martinique, she entered the world of human resources. At the Johner Institute, she is responsible for HR management and is the point of contact for employees, managers and the executive board. In addition, she oversees the recruitment process and the induction of our new colleagues, and is responsible for employee satisfaction and retention. She particularly enjoys interacting with different personalities.
Isabelle Pflug
Désirée Lüttich holds master's degrees in sociology and human resource management. With the conviction that employees are the key to the success of any company, she manages the HR department with great passion and commitment.
Désirée Lüttich, M.Sc.
Team Internal Services
As a specialist in financial accounting, Ana Lajn is an important contact person for the accounting department at the Johner Institute. Next to her work in accounts receivable for the Johner Institut, she is completing a degree in social work.
Ana Lajn
After 20 years of experience as a bank clerk at a large banking institution, Susanne Montau is very familiar with payment transactions. In the Internal Service Team, she keeps an eye on all incoming and outgoing payments and ensures that all invoices are paid on time.
Susanne Montau
Philipp Koppenhagen is a business information scientist who specializes in business process and IT management.
As a consultant, he supported our customers in the creation of technical documentation, QM systems and regulatory strategy.
He has been managing the Johner Institute's internal services since 2020, including finance, administration and compliance.
Philipp Koppenhagen
Team IVD
Dr Kai Moritz Eder, who holds a doctorate in chemistry, conducted research at Münster University Hospital on national and European projects involving the application of nanotechnology in medical devices and nano-based drug delivery systems. He developed and verified new imaging techniques for quantifying the toxicological effects of nanoparticles in vitro. With his experience in the development and verification of in vitro diagnostic tests, he supports Johner Institute customers in performance evaluation and the creation of product-specific technical documentation.
Kai Moritz Eder, Dr.
Dr. Juliane Havlicek is a biotechnologist and gained years of industry experience as a team leader. She was involved in the development of various in vitro diagnostic tests (IVDs). Her focus was on the implementation of regulatory requirements for their approval. She supports Johner Institute's clients regarding the creation of technical documentation, risk management, and performance evaluation of their IVDs.
Juliane Havlicek, Dr.
Tina Priewasser holds a PhD in Bioinformatics and did postdoctoral research on the simulation of sequence evolution. Afterwards, Tina gained more than 8 years of experience in a biotech start up, which later became an international diagnostics company in the field of liquid biopsy for cancer diagnosis. She was responsible for the evaluation of data from different analytical methods like PCR or NGS and a standard compliant software development of IVDs. At the Johner Institute, Tina supports clients in the technical documentation of software as a medical device or as part of an IVD.
Tina Priewasser, Dr.
Janos Hackenbeck is a trained medical physicist with many years of experience in software quality assurance and setting up software projects under IEC 62304 and ISO 13485. He is an expert in the development of medical device software. Based in Berlin, he supports Johner Institute customers with a focus on compliant software development in the field of IVD medical devices. His motivation lies in translating regulatory requirements into efficient development processes in order to remove barriers to the realisation of innovative medical devices with compliant and streamlined documentation.
Janos Hackenbeck, M.Eng.
After completing her studies, Claudia Volk gained several years of experience as a quality and regulatory affairs manager in a regulated environment, initially in food production and later as a management representative and PRRC for manufacturers of in-vitro diagnostics. She has set up, developed and audited QM systems and implemented digital QM tools.
At the Johner Institute, she supports clients in setting up and developing their QM systems and in training their employees. She is a certified Lead Auditor.
Claudia Volk, M.Sc.
Andreas Kalchschmid-Lehmann is an expert in in vitro diagnostics with over 17 years of experience in molecular diagnostics. He is the author of the book ‘ISO 13485 – Opportunity Instead of Obstacle’ and has extensive experience in QM systems (ISO 17025, ISO 15189, MDSAP, CFR 820) . As a laboratory manager, he gained detailed knowledge of processes in routine diagnostic laboratories, and as a former quality manager, he knows how to successfully set up a QMS for IVDs. He worked as a product specialist and lead auditor at a large notified body, where he assessed technical documentation for IVDs and QM systems.
Andreas Kalchschmid-Lehmann, M.Sc.
Dr Sophie Bartsch is a biologist and, after completing her doctorate, worked for three years as a research assistant in an accredited diagnostic laboratory. There, she was responsible for establishing NGS-based workflows. She then led the development of a molecular biology assay with machine learning-based evaluation software as laboratory manager. At the Johner Institute, she supports customers in the approval of IVDs. Her focus is on strategic product orientation and the creation of technical documentation.
Sophie Bartsch, Dr.
Dr Catharina Bertram supports Johner Institute clients in bringing IVDs to market and is an expert in performance evaluation. She assists in the preparation of technical documentation and advises on strategic product orientation. Her focus is on IVD assays and (AI-based) IVD software. With a PhD in biochemistry, she brings years of industry experience to the practical implementation of regulatory requirements. As branch and laboratory manager of a pharmaceutical start-up, she was involved in all QM processes and participated in the development of various IVD tests.
Catharina Bertram, Dr.
Team Johner Institut Schweiz
Urs Müller works as a consultant at the Swiss Johner office and supports clients and projects in the areas of product development and production equipment development for medical technology, with a focus on verification, validation (CSV) and software development. Since completing his degree in computer science, Urs has been working in the software development service sector, first as a test automation engineer/tester and later as a team leader in an engineering company focusing on medical device development. Quality-driven development is in his blood, and he enjoys sharing his enthusiasm for it with colleagues and clients.
Urs Müller, M.Sc.
Meet Mario Klessascheck, a dedicated Dipl. engineer with a profound devotion to the field of medical technology since his academic years. Specializing in medical systems engineering and functional safety, Mario brings forth a wealth of technical expertise and methodological acumen to aid development teams in translating the requisites of safety standards like IEC 60601-1 into practical solutions. Leveraging vast project experience, he's developed a comprehensive framework integrating human factors, technology, methodologies, and processes, enabling teams to navigate regulatory and technical challenges adeptly.
Mario Klessascheck, Dipl.-Ing.
Team Medical Device
As a human biologist, Manuela Reinhold offers advice on regulatory issues and approval strategies for medical devices at the Johner Institute. She was previously a scientist, then worked in Research & Development and served as Regulatory Affairs Manager for several medical device manufacturers. There she prepared technical documentation, supervised approvals for class I to III medical devices and gained experience in the implementation of regulatory requirements according to MDD and MDR.
Manuela Reinhold, Dr.
Medical informatics engineer Claudia Schmitt supports customers of the Johner Institute in standards-compliant software development (IEC 62304), risk management (ISO 14971) and management system setup (ISO 13485, ISO 27001). With 15 years of experience in medical device development and approval and as a quality management representative, she understands challenges and offers targeted support. Her enjoyment and knowledge of ISO 9001, ISO 13485 and IEC 62304 help companies to realize their visions.
Claudia Schmitt, Dipl.-Ing.
After her graduation in Biomedical Engineering and her studies of Regulatory Affairs Management, Katharina Keutgen worked many years in the development and regulatory affairs management of heart-lung machines and vascular access devices, where she acquired extensive regulatory expertise.
As a member of the Medical Device Team, she has been supporting the Johner Institute's clients with international approvals and questions relating to the regulatory strategy of medical devices since 2021 and conducts seminars and workshops on the topic of UDI and US FDA.
Katharina Keutgen
After graduating with his bachelor degree in 2017, Alexander Wassel got in touch with the Johner Institute for the first time. He then decided to participate in the master program 'IT in healthcare'. In addition to his studies, Alexander also worked as a software developer focused on web applications and cloud infrastructures. Alexander supports our clients with all questions regarding medical software. Besides being a software expert, Alexander also played handball sucessfully in Austria's National Handball League for more than ten years.
Alexander Wassel, M.Sc.
Christopher Seib is an engineer for chemical technology with a special focus on instrumental analytics. After his studies, he acquired several years of experience in the areas of quality management according to ISO 13485 and regulatory affairs of both in-vitro diagnostics and implantable medical devices. He advises customers of the Johner Institute on all issues related to the international approval of medical devices and supports them in meeting this challenge.
Christopher Seib, M.-Ing.
Alexander Thern supports manufacturers of medical devices and IVDs in setting up QM systems. He conducts internal audits against all MD and IVD regulations in German, English, French and Spanish. He accompanies certification audits and inspections by authorities and subsequent corrective actions. He can look back on many years of consulting and auditing experience.
He holds in-house seminars on "PRRC", "Medical Device Consultant MPDG", "MDSAP" and "Internal Auditor", as well as a two-day seminar on ISO 13485. Alexander Thern has lived in England and speaks fluent English. All Seminars are available in English. Alexander Thern is a freelancer for the Johner Institute. He is MDSAP Auditor.
Alexander Thern
Margret Seidenfaden supports the Johner Institute's clients in matters concerning international requirements for medical devices and product approval. She studied medical engineering and business administration and focused on quality management and regulatory affairs early in her carrier. Her passion is dedicated to diverse regulatory issues related to medical devices and helping manufacturers in overcoming challenges in international market approval processes. Before joining the Johner Institut in 2020, she was responsible for the planning, implementation, and monitoring worldwide product registrations.
Margret Seidenfaden, MBA
As a biomedical engineer, Christian Rosenzweig was responsible for basic and software development for complex active medical devices for many years. He was in charge of conformity assessment procedures in the EU and gained experience with all forms of audits and a wide variety of markets (in particular FDA, MDSAP) as well as serving as ISO13485 QM representative in a large corporation. As a sought-after expert, he supports our customers in strategic issues and in the implementation of quality and regulatory affairs management with a focus on medical device safety, risk management and IT security.
Christian Rosenzweig
Dirk Bethäußer has been working in quality management and approval at various medical device manufacturers for over 20 years. He has established, maintained and continuously developed QM systems. He is also an experienced auditor and currently a member of the standards committee. He supports the Johner Institut's customers in setting up, implementing and maintaining QM systems. In addition, he supports customers with certification in accordance with EN ISO 13485 and has already audited QM systems before joining the Johner Institute.
Dirk Bethäußer
Team Quality Management Systems
Sandra Brecht enjoys supporting our clients in establishing, maintaining and continuously improving viable and efficient quality management systems for the benefit of the company and its employees.
Before joining the Johner Institute, she was a quality management representative for a quality management system certified according to EN ISO 13485 and ISO 9001 at the Technical University of Munich for several years.
There she not only advanced quality management with joy and commitment, but also developed medical devices for minimally invasive surgery herself.
Sandra Brecht, Dr.
Team Seminare
As a seminar administrator and office manager, I am passionate about organising online and in-person seminars, from planning to evaluation, drawing on my international experience. My focus is on communication with lecturers, event planning and internal event management. In addition, I support projects in finance, legal and back office and take on a wide range of administrative tasks. I am your contact person for all matters relating to location, service providers or facility management. I look forward to working with the team to deliver successful events. My motto: ‘Organisation is the key – communication is the way.’
Alma Moric
Daria Salvatore has joined the Seminar Admin Team in January 2017. She is responsible for seminar organization, seminar planning and the positive experience of our participants in seminars at Johner Institute. She will be glad to answer any questions you may have about our seminars.
Daria Salvatore
With 25+ years of experience in management diagnostics, coaching and organizational consulting/development, Susanne Exler leads corporate culture, HR and organizational development and external training at the Johner Institute. She is committed to deeply anchoring corporate values and as an expert in Holacracy, she ensures a deeper understanding and successful implementation of this special organizational structure, which is essential for corporate culture.
Susanne Exler
Team Usability
After completing her master's degree in mechanical engineering with a focus on medical technology, Cathrin Lechner worked as a usability engineer at an IVD manufacturer for over 3 years. She was involved in the development of modern and user-friendly diagnostic systems. Since 2023, she has been supporting the Johner Institute's usability team with great commitment and helps our customers to carry out a successful, regulatory-compliant usability engineering process.
Cathrin Lechner, M.Sc.
Philipp Schleer studied mechanical engineering and focused on medical technology during his master's degree. In the course of his doctorate, he discovered his passion for human-machine interaction when he developed and evaluated assistance systems for robotic surgery from a usability perspective. At the Johner Institute he supports customers in the planning and implementation of major projects, usability tests, the introduction of usability processes and the documentation according to IEC 62366.
Philipp Schleer, Dr.
Ann-Kathrin Dessel is passionate about the optimal and holistic interaction between people and technology. With her professional background in psychology and her specialisation in human-machine interaction, she is motivated to support the development of appropriate product solutions. At the Johner Institute, she supports customers in the planning and implementation of usability tests and in the creation of usability documents in accordance with IEC 62366.
Ann-Kathrin Dessel, M.Sc.
Sophia Schwaeppe is a psychologist and during her studies, she focused on human factors engineering. On behalf of the Fraunhofer Institute, she researched user requirements for the area of smart home development. At the Johner Institute, she supports customers in planning and conducting summative and formative evaluations. As well as in creating usability documents according to IEC 62366.
Sophia Schwaeppe, M.Sc.
Wolfgang Schneider is a qualified psychologist and works for the johner institut as senior usability engineer. He advises clients on user interfaces for medical devices, carries out heuristic evaluations based on current standards and usability tests as part of formative/summative evaluations, and prepares the necessary documentation. For many years, he was actively involved in standardization committees of DIN/ISO (ISO 9241-series) and the DKE (IEC 62366-1/-2).
Wolfgang Schneider
Team Vertrieb
As a logistics graduate with a focus on business administration, Florian Wettlaufer has gained extensive experience in the areas of sales, customer success management, and resource planning.
At the Institute, as an Account Executive, he is responsible for bringing our customers together with the right experts and solutions at all times so that they can achieve their respective goals quickly and reliably.
Florian Wettlaufer
