The Johner Institute Consulting Team

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.

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.

Vanessa-Alexandra Vasile already supported the consulting team of the Johner Institute during her studies of health informatics. Since successfully completing her studies, she supports the Johner Medical team as a consultant. With a lot of enthusiasm she supports customers in the compliant approval of their medical devices and taking on regulatory roles, such as the role of authorized representative and responsible person. The creation and review of technical documentation in accordance with the MDR is one of her areas of expertise. Above all, good and timely customer support is very close to her heart.

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.

Margarita is the Lead Link of the Regulatory Roles team at Johner Medical. With over 15 years of experience in the regulatory affairs field, she supports clients as a qualified MDSAP auditor and in the role of external QM representative according to ISO 13485 (5.5.2) and external responsible person according to Article 15 MDR/IVDR. Additionally, together with her team, she represents the role of the Authorized Representative in Europe, Switzerland, the United Kingdom, and as US-Agent for the States. Margarita's extensive knowledge and expertise ensure compliance with both local and international regulations.

Susanne Golombek supports our clients as a consultant in the field of clinical evaluation and clinical trials. After completing her master's degree in molecular biotechnology, she worked as a research assistant in the field of preclinical cancer research. She then worked for several years in the field of clinical research as a monitor of clinical studies and developed further in the field of regulatory affairs for medical devices, where she supported researchers in setting up their technical documentation and the needed documentation for clinical trials. In this context, she was also a speaker for GCP investigator courses. Ms. Golombek has been supporting our clients with her interdisciplinary expertise in the field of Clinical Affairs since 2023.

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.

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. 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.

Lea Wettlaufer is a molecular biologist. While writing her master’s dissertation, she worked in molecular oncology research with a focus on therapy resistance in lung cancer cells. She is a certified Clinical Research Associate. Prior to joining Johner Institute, she has worked in a CRO specializing in writing clinical evaluations. Therefore, her expertise lies within the field of clinical trials and clinical evaluation. At Johner Institute, she supports our customers in creating clinical evaluations according to MEDDEV 2.7/1 rev. 4.

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.

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.

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

Robert Linde has been part of the Johner Institute since completing his degree in Computer Systems in Engineering at Otto von Guericke University Magdeburg. During his studies, he gained extensive and varied experience in the development of a start-up. He now uses the knowledge he has gained in the field of software development to further develop the Johner Institute's products.

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 previous professional experience, she brings expertise in the management of software projects in the field 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 process and documentation manager for software development projects in the fields of vascular surgery and radiotherapy.

Perla Gjoka studied Computer and Information Science at the University of Konstanz. Directly after completing her studies, she joined Johner-Institut. Perla already worked as a Software Developer during her Master Studies and gained the necessary experience needed to support our developing team. Her focus is the enhancement of existing Software and the development of new ones.

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.

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.

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.

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).

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.

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.

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.

Matthias Weiss supported the Johner Institute already during his Health Informatics studies. Since completing his studies successfully, he has been an integral part of the E-Learning team. He assists the team as a Technical Product Owner in the technical advancement of the E-Learning products and customer support. He develops solutions for complex issues with great joy, aiming to make the E-Learning products even more intuitive and user-friendly. An agile approach, working with Scrum, and continuous learning are particularly important to him.

Already during his studies, Maximilian Fletschinger supported the Software Development & Infrastructure Team of the Johner Institute. After his graduation in Informatics with a focus on software engineering, he is now responsible for the development of new software solutions as well as the support of existing ones.

After studying business informatics and then completing his master's thesis on the development and design of software to support the post-market surveillance of medical devices as part of his master's degree in computer science, nothing stood in the way of his entry into the industry. He has been a loyal companion of the institute since 2018. First as a consultant for the development and regulatory compliance of quality management systems and technical documentation and since August 2021 as a product owner in the e-Learning team. There he supports the content and technical development of our e-learning products using requirement engineering as well as product discovery methods and more.

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.

Isabelle Pflug studied International Business 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 Institut, she is responsible for HR-Management and is the contact person for employees, leaders and the executive board. She also oversees the recruitment process and the induction of our new colleagues and is responsible for employee satisfaction and retention. She particularly appreciates the exchange with different personalities.

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.

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.

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.

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.

Anna Panayotova is as a specialist for financial accounting, the first point of contact for all accounting questions. As an integral and important part of the Internal Service Team, she is responsible for accounts receivable and dunning.

Kai Moritz Eder holds a doctorate in chemistry and conducted research at Münster University Hospital on national and European research projects on the application of nanotechnology in nano-based drug delivery systems. He has developed and verified new imaging methods to quantify toxicological effects of nanoparticles on cells in vitro. With his experience in the development and verification of in vitro diagnostic tests, he supports the Johner Institute's customers in performance evaluation and the preparation of product-specific technical documentation.

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.

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.

Janos Hackenbeck studied medical physics. With many years of experience in software quality assurance and in 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 clients of the Johner Institute with a focus on the compliant development of software in the field of IVD medical devices. His incentive lies in the implementation of regulatory requirements in efficient and lived development processes in order to remove hurdles in the realisation of innovative medical devices with compliant and at the same time lean documentation.

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.

Sophie Bartsch is a biologist and worked as a research assistant in an accredited diagnostics laboratory for three years after completing her doctorate. In addition to routine diagnostics, she was also responsible for establishing NGS-based workflows. Subsequently, as laboratory manager, she was responsible for the development of a molecular biological assay with machine learning-driven evaluation software. At the Johner Institute, she supports our clients in the approval of IVD medical devices. Her main focus is on strategic product alignment and the product-specific preparation of the technical documentation.

Catharina Bertram supports Johner Institute’s customers in placing their in vitro diagnostic (IVD) medical devices on the market. She is an expert in the performance evaluation of IVD medical devices. Catharina contributes to the product-specific preparation of our customers‘ technical documentation and advises on strategic issues focusing on IVD assays and IVD software, particularly AI-based software. With a Ph.D. in biochemistry, she gained years of industry experience and now transfers her expertise to practical concepts for implementing regulatory requirements. As branch and laboratory manager of a pharmaceutical start-up, she contributed to all QM-related processes. Furthermore, she was involved in the development of various IVD medical devices.

Andreas Kalchschmid-Lehmann is an expert in in-vitro diagnostics with more than 17 years of practical experience in molecular diagnostics. He is the author of the book "ISO 13485 - Obstacle or Opprotunity?" and has relevant experience in other QM systems, including ISO 17025, ISO 15189, MDSAP and CFR 820. As a laboratory manager he gained detailed knowledge of processes in a routine diagnostic laboratory and as a former quality manager he knows how to successfully set up and live a QMS for IVDs. He worked as a product specialist and lead auditor for a large Notified Body where he assessed technical documentation of IVDs and QM systems.

Urs Müller works as a consultant in Johner's Swiss office and supports customers and projects in the areas of product development and development of production equipment for medical technology with a focus on verification, validation (CSV) and software development. Since graduating in computer science, Urs has been moving in the service environment of software development, first as a test automator/tester and later as a team leader in an engineering company with focus on medical device development. Quality-driven development is in Urs' blood and he likes to share his enthusiasm for it with colleagues and customers.

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.

Tea Bodrusic supports the Johner Institute in marketing and ensures holistic and always value-oriented communication across all our channels. She gained her first practical experience in the medical technology industry during her dual bachelor’s degree. She completed her master’s degree in business management with her thesis at the Johner Institute.

Nadine Kaffer has been working as an event manager in the field of medical technology since 2008. In close cooperation with Prof. Dr. Christian Johner, she developed the innovative concept of the Medical Device Days in Berlin. In 2019, the Speed Consulting Conference took place for the first time and has since become an integral part of the Institute's annual training and networking events. She has been a permanent employee at the Institute since June 2021 and organizes the annual Institute Day in Constance in addition to the Medical Device Days Berlin. She is also the contact person for trade fair appearances and participation in external events.

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.

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.

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.

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.

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.

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.

Luca Salvatore has been advising the Johner Institute on regulatory issues relating to medical devices since 2015 and heads the International Regulatory Affairs department. He focuses on MDR, FDA and NMPA issues and is responsible for key accounting and knowledge management. After graduating in Computer Science (2006), he worked at a medical device startup as a software developer and then as Quality Manager and Head of Regulatory Affairs, gaining experience in quality management and international regulatory affairs.

As an engineer specializing in biomedical engineering, Christian Rosenzweig started his professional career in basic development of complex active medical devices. He has then worked for more than 10 years in software development for medical devices. His daily work with regulatory requirements finally led him to quality management. In this field, he gained international experience as a quality management officer under ISO 13485 in a large corporation. He supports the consulting team at the Johner Institute.

After studying medicine and health management, Dirk Bethäußer worked for several years in quality management and regulatory affairs at various medical device manufacturers. 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.

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" 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.

Micha Freudenberg is a digital strategist and driving force. With his entrepreneurial experience in the areas of digitalization, sales and online marketing, he supports the Johner Institute in the business development of the seminar and academy business. His tasks include evaluating new market opportunities, analyzing customer and product potential, developing new business opportunities and designing new sales and business models.

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.

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.

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.

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.

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.

Wolfgang Schneider is a Dipl. psychologist and has been advising companies as a usability expert for over 20 years (heuristic evaluations based on standards, walkthroughs, usability tests, workplace observations, documentations). He is involved in the responsible standardization committees of DIN/ISO (amongst others as editor of part ISO 9241-125 - visual representation of information) and the DKE (IEC 62366-1/-2). He worked as an author, e.g. for DGUV Information Softwareergonomie and the publisher Beuth. He supports Johner Institute in terms of usability.

Nils Becker is a Dipl. biologist. Conducting his doctorate, he researched the molecular mechanisms of neural plasticity. Prior to joining Johner Institute, he was involved in regulatory affairs, usability, and technology transfer. At Johner Institute, he supports customers in the planning and execution of usability tests as well as in the creation of usability documents pursuant to IEC 62366 and FDA requirements.

Marcel Heimerl learned the trade of a customer service with solutions in need of explanation in his bank training. As an Account Executive and CRM-Manager, Marcel Heimerl accompanies our customers through the institute from the idea of a medical product to its implementation. Here he takes care of linking projects with the right experts, developing solutions and being there for our customers as a constant contact person.

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.