We ourselves are people who, from the heart, are passionate about developing medical software and have years of experience in this field. We have participated in countless audits, as auditees as well as a companion for companies. With us, you can discuss the latest technologies and software architecture as well as the automation of your test process.
We have a very good understanding of medicine and medical terminology. We are experts in this area because we mainly operate in the healthcare industry and it is so to say, our main focus. With this specific knowledge, we can also carry out risk analyses and provide the interface for clinical testing.
Being a long-standing consultant and managing director of companies in the field of software applications, Mrs. Arndt knows what is important in the design and adaption of processes. Her expertise in setting up quality management systems and creating technical documentation is based on the introduction of an innovative medical device which she led as the responsible quality manager. At Johner Institute, Mrs. Arndt focuses on technical documentation of medical software and health software.
As a Dipl. economist and labor economist, Astrid Schulze keeps an overview before delving into details of the regulations on the approval of active medical devices in Europe and North America. For more than two decades, she has successfully advised companies on quality management according to 13485 and on the market launch of their medical devices and software in her own company. Astrid Schulze supports the regional presence of Johner Institute in the Berlin-Brandenburg area in terms of quality management and technical documentation.
Benedikt Simon is a medical physicist with a master's degree in Biomedical Engineering and has programmed software in a medical context during his studies. During his time at the Johner Institute, he was part of two MedTech start-ups (Active Implantable and SaMD), where he was responsible for establishing a QM system according to ISO 13485 and supervising product development from a regulatory perspective.
Mr. Simon supports our customers in setting up QM systems, implementing risk management, and creating technical files.
The physicist graduate, Christian Johner, is the founder and owner of the Johner Institute for Healthcare IT. He is an internationally renowned expert for medical software. As a professor in several universities, his lectures are in the field of software architecture, software engineering, software quality assurance and medical computer science. His consulting focus is in the lean implementation and implementation of quality management systems, processes and tools.
Find out more on the profile page of Christian Johner.
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.
As an electrical engineer, Daniel Reinsch spent many years as a software developer and software sub-project manager developing safety-critical software for medical devices and writing the technical documentation for it. At the Johner Institut location Berlin he supports customers regarding the technical documentation of medical device software (IEC 62304, ISO 13485, ISO 14971). His goal is to ensure that the compilation of the technical documentation does not become an obstacle in the development of safety-critical software, but rather serves as a support.
Dimitrios Kaloulis, as a member of the Johner Medical team, supports customers in the preparation of technical documentation and the establishment of QM systems in accordance with MDR 2017/745 and ISO 13485. 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.
After finishing his studies, Dirk Bethäußer worked for many different medical device manufacturers in the field of quality management. In doing so, he has built up QM systems, maintained and continually refined them. He supports the customers of the Johner Institut with the setup, implementation, and maintenance of QM systems. In addition, he supports the customers with the certification according to the EN ISO 13485. Before his work at the Johner Institut, he has already audited QM systems.
Franziska Reichel is a microbiologist who 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 ??QM systems and the preparation of technical documentation.
Maike Andersson holds a degree in biology with a focus on secondary plant compounds. Before joining the Johner Institute, she worked for many years as a medical writer in the areas of medical science, medical affairs and pharmacovigilance at a Hamburg-based service provider for the pharmaceutical and medical device industry. She is an expert in substance-based medical devices with and without drug components. Through her work with a legal manufacturer, she has also gained insight into the specific challenges posed by the implementation of the MDR, also and in particular for material medical devices.
Maria Keller supports our customers in quality management out of our Berlin office. In particular, her focus lies on developing and improving QM systems, including the integration of digital tools to manage the entire QM and development documentation.
Prior to joining Johner Institute, she was quality manager at a start-up in the field of active implants. There, she was responsible for the QMS certification pursuant to
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. He supports the customers of the Johner Institut in the field of consulting and is especially responsible for the management of the Consulting Circle as well as for consulting with the focus on strategy development, medical device software, risk management and quality management systems.
Being a typical practitioner and having worked in emergency rescue for a long period of time, medical devices have always been a major area of interest for Oskar Fuerleger. As part of his medical engineering degree, he developed a passion for the interaction between application, development, and regulatory requirements. Upon graduation, he joined a medical device manufacturer in the department of regulatory affairs and quality management.
Based at Johner Institute in Constance, Germany, he supports the creation of technical documents and advisory for quality management systems.
Philipp Malsch studied molecular medicine in Erlangen and received his doctorate in Innsbruck in the field of neuroscience with a focus on pain. After his academic career, he worked in the pharmaceutical industry in the field of regulatory affairs/CMC. Prior to joining the Johner Institute, he worked as a quality manager and was responsible for setting up the QM system at a Norwegian medical device start-up. He supports our customers at Johner Institute in the areas of QM systems and technical documentation.
Sebastian Lettau first completed his degree in business informatics in Konstanz and then continued with his master in computer science. Already during his master thesis, he designed a software to support the post-market surveillance of medical devices.
He supports our customers in developing standards-compliant medical devices, laying his focus on medical software. He creates, improves and checks software files as well as the general technical documentation and helps to set up ISO 13485-compliant QM systems.
With Alexander Thern, the institute has been able to win a lead auditor for the Quality Management Standard ISO 13485. He shares the common vision of lean QM-systems that contribute to real improvement in quality and more cost-effective development and production. Alexander Thern looks back on many years of consulting and audit practice.
Alexander Thern holds the seminars for the Johner Institute: "PRRC Person responsible for regulatory compliance" and "Internal Auditor", as well as the seminar on ISO 13485. Alexander Thern has lived in England and speaks fluent English. All Seminars are available in English as inhouse Seminars. Alexander Thern is a freelancer of the Johner Institute.
As a doctorate graduate biologist, Dr.Martine Günderoth has been working for over 15 years in the medical technology field, including over a decade of working in her own company. Since 2002, she has been consulting costumers in the process of creating QMS and is a certified QM auditor since 2004.
Dr. Günderoth has a track record over many years of experience in the clinical research, product management in IVD-Manufacturers and in QMS audits. Dr. Martina Günderoth is a freelancer of the Johner Institute.
Robert Dick-Hambeck has been intensively involved in the development and market approval of medical devices for more than 15 years. As a graduate engineer for precision engineering, he has worked for manufacturers for 10 years and as a consultant for 8 years. Therefore, his knowledge of international regulations, especially MDD/MDR, 21 CFR, and the "Guidance" documents, as well as the relevant standards, such as IEC62304, IEC62366, ISO13485, ISO14971, IEC60601, is accordingly deep. He supports the Institut as a generalist with the set-up of complete QM systems, the improvement of processes, the definition of product definition and approval strategies, as well as the creation of technical documentation. He is an expert for modular damage and IT security risk management.
Andreas Kalchschmid is an expert for in-vitro diagnostic devices with more than 16 years of hands-on experience in using and developing molecular diagnostic assays. He was working in a variety of accredited, certified and compliant QM systems, including ISO 17025, ISO 15189, ISO 13485 and 21 CFR part 820.
As a Laboratory Manager he gained in-depth knowledge of processes in a routine diagnostic lab, and as a former Quality Management Representative he knows how to successfully set-up and live a QMS for IVDs including EU and FDA compliant design and development.
Before joining Johner Institute he was working as a Product Specialist and Lead Auditor at a big Notified Body, where he assessed Technical Documentations and QM Systems, including IVDR and MDSAP, and where he also was involved in implementing requirements for the accreditation as a Notified Body for the new IVD Regulation.
Catharina Bertram holds a doctorate in biochemistry and has more than 10 years of experience in the fields of pharmaceuticals and in-vitro diagnostics (IVD). As branch and laboratory manager of a pharmaceutical start-up, she was involved in all processes from the implementation of the QM system to the attainment of the GMP and ISO 9001 certificate and routinely performing the required tasks. In the following, she drew on these experiences when developing two in-vitro diagnostic tests. These are stand-alone software and a molecular biological assay. She supports the Johner Institute's customers in the approval of IVDs. This includes, amongst others, writing the technical documentation, performing and documenting the performance evaluation of IVDs, implementing QM systems compliant with ISO 13486, as well as implementing the standards IEC 62304 and ISO 14971.
Katrin Schnetter is our expert for IVD software. She has more than 15 years of experience in the introduction and certification of QM systems according to EN ISO 13485 and in the implementation of software development processes in a regulated environment. Ms. Schnetter supports our customers with the introduction of standards-compliant processes according to IEC 62304, IEC 62366 and ISO 14971. She assists our customers with the approval of the IVD software and guides you safely through the audits.
Sebastian Groemminger is molecular biologist and expert in the field of molecular genetic in-vitro diagnostics. At Johner Institute, he supports clients in the certification, development and maintenance of QM systems according to EN ISO 13485, as well as in the implementation of the standards EN 62304 and EN ISO 14971, and the approval of in-vitro diagnostics.
Following his doctorate in the field of virus-associated tumor development at the Helmholtz Centre in Munich, he played a decisive role in the development, practical implementation, approval, and performance evaluation of non-invasive prenatal examination methods. With his experience in development and diagnostic routine, he has taken over Quality Management and Regulatory Affairs.
Sophie Bartsch holds a doctorate in biology and has extensive knowledge and several years of experience in routine molecular diagnostics. During her time at an accredited laboratory, she additionally established NGS-based workflows. Prior to joining the Johner Institute, she was responsible for the development of a molecular biological assay as laboratory manager. Thereby, she worked in close cooperation with bioinformaticians for the identification of new biomarker candidates via machine learning models. Sophie Bartsch holds a doctorate in biology and has extensive knowledge and several years of experience in routine molecular diagnostics. During her time at an accredited laboratory, she additionally established NGS-based workflows. Prior to joining the Johner Institute, she was responsible for the development of a molecular biological assay as laboratory manager.
Ulrich Hafen is a molecular biologist. After his studies in Constance and Innsbruck, he researched the development of Parkinson's disease at Helmholtz Centre in Munich. He can draw on a broad spectrum of molecular biological and genetic methods.
Ulrich then worked in in-vitro diagnostics and medical technology as a quality manager. He is a specialist in developing and maintaining QM systems according to ISO 13485 and is a certified supplier auditor.
Bernhard Gerstenecker holds a doctorate in microbiology and has devoted his entire professional career to all aspects of IVD systems. For around 25 years, he has been developing immunochemical reagents and assays, establishing and further developing QM systems, and has been handling regulatory affairs requirements.
Since 2010, he has been working as a quality manager and regulatory affairs manager in the IVD device industry. Dr. Bernhard Erstenecker is a freelancer of the Johner Institute.
Martin Elmlinger has been a medical researcher and passionate expert in in-vitro diagnostics and biomarker development since 1994. As head of the diagnostic laboratory (ISO 15189) at the University Children's Hospital in Tubingen, he developed and validated clinical laboratory tests in cooperation with IVD manufacturers. Working as a strategist for biomarker development in the pharmaceutical industry from 2005 onwards, he developed diagnostic biomarkers for many medical indicators. He oversaw the process from preclinical and clinical development to the approval of drugs and vaccines. He further advises medical technology start-ups.
Martin Elmlinger assists clients of the Johner Institute as a freelance consultant with questions regarding development, legally compliant documentation, planning and clinical performance evaluation of IVD medical devices and biomarkers, LDTs, and Companion Diagnostics. Martin Elmlinger is a freelancer of the Johner Institute.
Bettina Martin is a molecular biologist and received her doctorate in the field of neuroimmunology with a focus on multiple sclerosis at the Max Planck Institute in Munich. In addition to her doctorate, she completed an additional qualification as a Regulatory Affairs Manager at the University of Lübeck. Before joining the Johner Institute, she worked as a project manager in the field of Medical Scientific Affairs for a large medical technology group. As a specialist for clinical evaluations, preclinical as well as PMCF studies, and with clinical expertise in risk analysis, she contributed to the revision of the entire portfolio according to MDR. She supports the Johner Institute as a consultant in clinical affairs and as an expert for clinical evaluations.
Doreen Soeder is an engineer in medical technology. As part of her master's thesis, she has dealt with the implementation of MDR in the given project and personnel structure of small and medium-sized enterprises. Prior to joining the Johner Institute, she has gained experience in the field of technical documentation, quality management according to EN ISO 13485, and product management. She supports the clients of the Johner Institute as a Clinical Affairs Manager and among other things with the writing of clinical evaluations according to MEDDEV 2.7 / 1.
As a specialist in general medicine, Gisela Knopf is the medical advisor at the Johner Institute. With her broad medical expertise, which she owes to her many years of clinical and general practice experience in conservative as well as operative specialties, she ensures medical and clinical consistency of clinical evaluations and studies. In addition, she has many years of experience in study design, "Good Clinical Practice" and the associated regulatory and legal systems. Thus, she combines the demanding scientific and formal standards with the needs of practice, conducts training, and works constructively in the area of clinical evaluations and clinical trials.
Julia Renz is a biologist specializing in molecular biology and biochemistry. As part of her master's thesis, she investigated molecular processes for the regulation of DNA translation by microRNAs. Prior to joining the Johner Institute, she worked for a CRO specializing in the conduct of clinical trials and clinical evaluation of medical devices. Additionally, she is a certified Clinical Research Associate. She supports the clients of the Johner Institute in the field of clinical affairs, in particular in the preparation of clinical evaluations according to MEDDEV 2.7 / 1 rev. 4.
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.
Nadine Jurrmann holds a doctorate in biology and has been working for a medical device manufacturer for more than six years. There, she has been responsible for the preparation of clinical evaluations. Her tasks further included the planning, execution, and evaluation of PMCF studies on the newly developed medical devices. Thus, her expertise lies in post market surveillance and clinical evaluation. At the Johner Institute, she supports our customers in creating clinical evaluations compliant with MEDDEV 2.7/1 rev. 4.
Ruth Dittmann is a graduate engineer for ophthalmic optics. She has many years of experience in the medical technology industry. Prior to joining the Johner Institute, she worked for a leading manufacturer of ophthalmic medical devices and a CRO specializing in clinical trials and clinical evaluation of medical devices. She has been responsible for the clinical evaluation of various medical devices, as well as the planning and execution of clinical trials. At the Johner Institute, she supports our clients with her expertise in the field of ophthalmology but especially with the preparation of clinical evaluations according to MEDDEV 2.7 / 1 rev. 4.
Since the beginning of his career in 2009, Pierre Jäger has been involved in the development of security-critical systems. As a system engineer and project quality manager, his main focus is the implementation of regulations and standards in development projects. For the past three years his core field is mainly product development in the area of medical technology, especially software development and verification compliant with IEC 62304, ISO 13485, ISO 14971.
In the Johner Institute, Pierre is responsible for our customers in the field of quality management and creating technical documentation
Andrea Seeck is a medical technology engineer and has many years of experience in research and development of innovative processes and products, especially in the eHealth segment. Before joining Johner Institute, she worked as a medical & regulatory affairs manager and in quality management.
She helps customers of Johner Institute with writing clinical evaluations pursuant to MEDDEV 2.7/1 as well as with setting up and maintaining QM systems.
Ann-Kathrin Dessel is passionate about the optimal and holistic interaction between humans and technology and is motivated to support the development of appropriate product solutions. In her master's degree in psychology, she specialized in human-machine interaction and completed this with her master's thesis - an explorative analysis of current user-centered design practice. At the Johner Institut she supports customers in planning and conducting usability tests and in creating usability documents according to IEC 62366.
Immanuel Bader heads the usability / human factors department at the Johner Institute and is Chief Executive Officer of the Johner Institute North America Inc.
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.
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.
Luca Salvatore helps our customers both in writing the technical documentation and authorisation documents and in creating QMS. As an informatics professional, he was involved in university based medical products startup as software developer at the beginning and later on as quality manager.
Before joining Johner Institute, he has done QMS audits and is now engaged in a standard committee DKE 811.3.1 (Medical Software, responsible for IEC 62304, etc)
Margret Seidenfaden supports the Johner Institut customers regarding questions and challenges concerning international product approval. She studied medical technology and business administration and focused on quality management and regulatory affairs. In these areas ,she worked for two medical device manufacturers. Her passion, however, is dedicated to diverse regulatory issues surrounding medical devices and the manufacturers’ challenges in international product approval processes. Before joining the Johner Institut and among others, she was responsible for the planning, implementation, and monitoring of worldwide registrations.
Mario Klessascheck is a Dipl. engineer and has been passionately "married" to the medical technology industry since his studies. His focus lies on medical systems engineering and the associated topic of functional safety. In this context, Mr. Klessascheck supports development teams with his technical and methodological knowledge in the practical implementation of the requirements of IEC 60601-1 and co. He likes to think outside the box and applies proven analog concepts such as ones from the field of mechanical engineering.
Based on his experience gained in numerous projects, Mr. Klessascheck has developed a powerful framework for medical systems engineering. This framework combines the aspects of people, technology, methods, and processes and enables teams to sustainably master regulatory and technical challenges.
Additionally, Mr. Klessascheck also teaches risk management in development at the Berne University of Applied Sciences. He is member of the association of Certified Professionals for Medical Software.
During his studies in computer science, Julian Voegt has specialized in business process and IT management. For many years, he has been responsible for our e-learning platform and supports our customers in the creation of technical documentation and the development of QM systems.
Hendrik Rudolf is as an engineer in chemical- and biotechnology for 10 years 100% focused on the field of biocompatibility (in vitro) of medical devices. As Head of Biocompatibility of a testing laboratory, he and his team supervised thousands of medical devices from the product development until the approval. He supports our customers in the field of biocompatibility.
Margarita Rozhdestvenskaya has headed the EU representation of a non-European manufacturer of active medical devices for the last 8 years. On his behalf, she was the contact person for the authorities within the EU. It was her responsibility to check the completeness and conformity of the technical documentation as well as to fulfill the notification and reporting obligations. With her broad experience, she supports the customers of Johner Medical as a certified auditor for QM systems. More precisely in the legal marketing of medical devices in Europe according to ISO 13485, by taking on the role of the safety officer for medical devices or the responsible person and by writing and checking the technical documentation.
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.
Anna Ivanova 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.
Annegrit Reuter studied management and Chinese, which she is even fluent in thanks to a one-and-a-half-year study visit to Asia. With her enthusiasm for people and processes, she is responsible for all HR administrative matters and is also the contact person for applicants. She always finds solutions and provides support to her colleagues. As a safety officer, she is also concerned about well-being in the workplace.
Daniela Reitmeier supports Internal Services in ensuring that all administrative processes run smoothly. Another major task is the seminar administration, where she is in charge of the seminar administration. She plans and organizes the seminars at all Johner Institute locations and is responsible for the all-round support of our seminar participants in Constance.
Daria Salvatore is part of the Seminar Admin Team and takes care of the well-being of the seminar participants at our location in Frankfurt am Main. In addition, she supports Internal Service with accounts receivable and accounts payable.
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.
With more than 20 years of experience in personnel selection and development, management diagnostics and test design, Susanne Exler is the contact person for all internal HR questions at the Johner Institute. She also supports our customers with the selection of new employees. Together with our specialists, she develops diagnostic procedures such as subject-specific aptitude tests and case studies, which allow us to determine the professional competence and personality traits of applicants.
Philipp Koppenhagen is a computer scientist specializing in business process and IT management. He has been overseeing Auditgarant since its early times and is therefore very familiar with anything concerning Auditgarant. For our customers, he creates technical documentation and supports them in setting up QM systems.
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 Software Development & Infrastructure team in further developing existing software as well as developing new software solutions.
Felix Hohlwegler is a passionate computer scientist and has several years of experience in software development. As head of the Johner Institute's Software Development & Infrastructure Team, his focus is the support and further development of existing as well as the development of new software solutions by the Johner Institute. At the same time, he is a lecturer in software architecture at HTWG Konstanz.
Already during his studies, Maximilian Fletschinger supported the Software Development & Infrastructure Team of the Johner Institute.
After his graduation in Business Informatics with a focus on software and system development, he is now responsible for the development of new software solutions as well as the support of existing ones.
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.
Raphael Sterk worked during and after his studies in the software industry, including the development of online shops and the integration of systems in companies. With his enthusiasm and expertise in software development and the technology behind it, he supports the Software Development & Infrastructure team in the further development of existing software as well as the development of new software solutions.
JIM is a loyal employee. He works day and night, delivers emails, informs us of enquiries, and reminds our customers, for example, when an Auditgarant license is about to expire.
JIM doesn't like to be called a bot. We don't quite understand why. But we respect his wishes. After all, such a piece of software is also just a human being.