Unsere Dienstleistungen umfassen alle Schritte der Produktentwicklung, von der ersten Projektidee bis zur Zertifizierung oder behördlichen Zulassung. Mit Standorten in der Schweiz, in Deutschland, Dänemark, Belgien, APAC und in den USA ist Medidee ein globaler Dienstleister, der Unternehmen aller Größen von akademischen Neugründungen bis zu großen Unternehmen begleitet und unterstützt. Medidee wurde von drei Partnern, alle Experten auf dem Gebiet der Medizinprodukte, gegründet. Als Experten mit multidisziplinärem Hintergrund stellen wir intern die notwendigen Kompetenzen zur Verfügung, um alle Aspekte Ihres Projekts vom Entwurf bis zur Zertifizierung abzudecken. Unser Team wächst stetig um alle Dimensionen Ihres Projekts abzudecken und die ehrgeizigen Meilensteine zu erreichen, die für die Vermarktung Ihres Produkts erforderlich sind.

Véronique Michel-Treil

Quality & Regulatory Affairs Director

Véronique is a clinical laboratory scientist, with more than 20 years’ experience in medical diagnostics and research laboratory settings. She led several hospital and private laboratories through successful quality accredi-tations. She held leadership roles in both Quality and Operations in an international Contract Research Organization (CRO), where she developed expertise in drug clinical trials and companion diagnostics (CDx). She led strategic development of molecular diag-nostic activities in 5 international sites located in Europe, USA, China and Asia-pa-cific. She oversaw innovative biomarker assays validation and implementation for diagnostics use in EU and US sites. Véronique focuses on regulatory and quality support for IVDs and clinical studies’ operation. She brings scientific expertise in Precision Medicine, Molecular Oncology, Phar-macogenomics, Infectious Diseases, Antimicrobial Resistance, and Immunoassays. Véronique speaks French and English.

Neville Rhodes

Quality & Regulatory Affairs Manager

Neville Rhodes is an Analytical Chemist by training and holds an MBA. He has more than a decade of experience at the senior executive level in the chemical, coatings, and automotive industries. Additionally, he completed a CAS CARAQA in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostics. He offers client support across various areas, including project management, regulatory strategy development, QMS maintenance, usability engineering practices, and preparing and reviewing technical documentation for regulatory submissions. Neville is proficient in English and possesses an intermediate level of proficiency in German.

Simone Rumac

Simone Rumac

Project Associate

Simone Rumac is a biomedical engineer (M.Sc. from the Polytechnique of Turin) with expertise in medical imaging and signal processing, advanced optimization, image reconstruction algorithms, and Machine Learning (ML). He specialized in the field of MRI physics, image acquisition and simulation frameworks in hospital settings, having worked at the Lausanne University Hospital (CHUV). He has also worked on speech-to-text technologies and ML as a software developer. Simone provides support on the regulatory aspects of medical device software, including its development in compliance with IEC 62304, validation of AI/ML-enabled medical devices, and clinical evaluation of Software as a Medical Device (SaMD). Simone is fluent in English and Italian.

Sara Morera Roca

Project Associate

Sara holds a Master’s in Biomedical Engineering from the University of Barcelona and the Polytechnical University of Catalonia. She has previously worked in various companies in design and engineering departments, where she gained experience in custom-made devices (prostheses and jigs) and serial production of implantable devices and single-use related instrumentation. She has experience working alongside surgeons and in usability engineering testing. Sara supports you in manufacturing process validation (IQ, OQ, PQ), preparation of technical documentation, management of suppliers and testing, and documentation for new product development. She has successfully conducted projects in the field of medical devices, such as technical file preparation for CE marking, risk management, QMS deployment and regulatory pathway analysis. Sara is fluent in English, Spanish and Catalan.

Dr Sergi Masgrau

Project Associate

Dr Sergi Masgrau is a biomedical scientist by training with an MSc in Biomolecules and Cellular Dynamics and a PhD in Medical Research in cardiovascular physiology and immunology. While conducting research at the Ludwig-Maximilians University of Munich, he gained expertise in various molecular biology and imaging techniques, alongside extensive experience in working with animal models. At Medidee, Sergi supports you in the review of the technical documentation for regulatory submission and in the related scientific aspects, such as the writing of clinical evaluations. He speaks fluently English, Spanish, German, and Catalan.

Dr Valentina Paggi

Project Associate

Dr Valentina Paggi is a microengineer with a strong expertise in biomedical systems. She holds a PhD in Microsystems and Microelectronics from EPFL and a joint MSc in Micro and Nanotechnologies from Politecnico di Torino, EPFL, and INP Grenoble. During her PhD, Valentina worked on the development of implantable devices for nerve modulation, gaining a deep understanding of the complexities and requirements of medical devices. With her multifaceted scientific background, she excels at designing and managing multidisciplinary projects, and has showcased her scientific writing skills through the publication of research and review articles. She supports you in designing preclinical studies, conducting clinical evaluations, preparing technical documentation, V&V, and engaging in regulatory activities. Valentina speaks English, Italian and French.

Dr Sandrine Isaac

Dr Sandrine Isaac

Project Associate

Dr Sandrine Isaac is a pharmacist with a Master’s in Parasitic Tropical Diseases. She holds a PhD in Biochemistry and Biomedicine, during which she developed gut microbiota-based solutions against multidrug-resistant bacteria. She then pursued a postdoctoral project at EPFL (Lausanne) where she was also study director for animal experimentation. Before joining Medidee, Sandrine provided support in clinical study conduct at the Department of Nephrology and Hypertension at CHUV (Lausanne). At Medidee, leveraging her expertise in preclinical and clinical studies, she provides support with clinical evaluation and clinical investigation of medical devices, in accordance with the applicable regulatory requirements. She is fluent in French, English and Spanish.

Saskia Dunkel-de Raad

Dr Saskia Dunkel-de Raad

Associate Director

Dr Saskia Dunkel-de Raad is a biochemist by education with 17+ years of experience in clinical studies of MDs and MPs from multiple perspectives: CRO, global sponsor, investigator and Swiss Competent Authorities. At Swissmedic, Saskia assessed and authorized/denied new applications and amendments of pre-market MD studies. In addition, she was responsible for the safety of study subjects in ongoing clinical studies and conducted routine and for cause inspections at investigators and sponsors. Saskia is an expert in the qualification and classification of products and accordingly was a Swiss member of the European Commission Borderline and Classification Expert Group. She also has deep experience in the request of humanitarian exemptions. Within Medidee, Saskia is overseeing all activities related to clinical studies, their quality and their regulatory and ethical compliance (ISO 14155 and GCP).
Saskia speaks French, English and German.

Veton Ahmedi

Veton Ahmedi

Business Controller

Veton holds an MSc degree in Finance & Accounting and has over three years of experience working as an auditor and over one year as an accountant with very close collaboration in financial planning and analysis. Before joining Medidee, he worked for a few years as an auditor in well-known audit companies. More recently, he worked as a senior accountant at a multinational corporation in Switzerland, where he gained valuable financial knowledge. His strong accounting background and experience are important assets to the finance team at Medidee. Veton speaks English, German, Albanian and Macedonian.

Dr Gerard Llimos

Dr Gerard Llimos

Project Associate

Dr Gerard Llimos is a biotechnologist by training and holds a Master’s in Systems Biology from the University of Luxembourg and the Roswell Park Cancer Institute. He also holds a PhD in Genetic Variations and Epigenetics from the Swiss Federal Institute of Technology in Lausanne (EPFL). Gerard has 6 years of experience in project design and management, data analysis and finally scientific writing and communication. At Medidee, Gerard supports you with the setup and review of the technical documentation for CE-marking, the strategy of clinical and performance evaluation for medical devices and in vitro diagnostic devices (IVDs), and, finally, with the setup and review of verification and validation activities particularly related to DNA sequencing, genetic engineering and digital health. Gerard is fluent in English, Spanish, Catalan and French.

Marie Stutzmann

Marie Stutzmann

Senior Associate

Marie Stutzmann is a biomedical engineer with a specialization in regulatory affairs for medical devices. She has over 5 years of experience working in different medical device companies. She has been in charge of the redaction of clinical and biological evaluation reports, and also worked as a toxicological regulatory expert at a major French medical device company. In this role, she provided support during the design and development of various medical devices, including the evaluation of the impact of change on biological safety, redaction of toxicological risk assessments, and biological evaluation reports. At Medidee, Marie provides clients with strategic and assessment support related to the biological safety of medical devices, as well as any other request related to biocompatibility and biological requirements, covering the full product life cycle. Marie speaks fluently French and English, with extensive knowledge of German.


Dr Shannen Chacko Rajan

Project Associate

Dr Shannen Chacko Rajan is a Bioengineer with about 6 years of research experience in academia. She completed her Master’s degree in Nanoscience and Technology with a special focus on Biomaterials. As a part of an exchange program during her Master’s, Shannen carried out experimental work on nanofibers for biomedical applications at Leuphana University, Germany. Further, she went on to do her PhD studies at Newcastle University, UK in Bioengineering, where she was researching to identify the causes of failure of retrieved knee prostheses using engineering techniques. During her PhD, she solely catalogued about 400 retrieved knee prostheses from various manufacturers and analyzed over 100 total and partial knee prostheses. Her knowledge of a wide range of tribological and material characterization techniques, combined with her scientific expertise in the field of prostheses analysis, allows Shannen to support you in establishing clinical evaluation of medical devices. Shannen speaks English, Hindi, Malayalam, Telugu and Tamil.

Dr Melina Maamir - Medidee

Melina Maamir, MD

Project Associate

Melina Maamir is a Medical Doctor with a passion for the medical device industry. She worked in the hospital as a general practitioner where she gained profound scientific knowledge and understanding of clinical needs. Melina holds a Master's Degree in International Healthcare Management from the International University of Berlin. Before joining Medidee, she worked in a medical device company where she performed medical writing work and redaction of clinical evaluation reports. At Medidee, Melina supports you with regulatory strategies, risk management, technical documentation and clinical aspects. Melina is fluent in French, English and Arabic.

DR Elisabeth Hirth

Project Associate

Dr. Elisabeth Hirth holds a BSc in Chemistry (HTW Aalen) and an MSc in Chemical Biology (KIT). Elisabeth conducted part of her studies in the US where she gained experience in microfabrication (UTEP) and translational medicine (Harvard Medical School). During her PhD at ETH Zurich, she focused on the development of microfluidic platforms to mimic the human vasculature for further translational applications. Elisabeth has a solid scientific background, with expertise covering medical and scientific writing, as well as regulatory aspects. Elisabeth supports you on regulatory activities and biological risk assessments. She is fluent in German and English.

Dr. Sebastian Augustin

DR Sebastian Augustin

Project Associate

Dr. Sebastian Augustin is a biologist by training and holds a Bachelor’s and Master’s degree from Heidelberg University. He holds a PhD in molecular biology and protein biochemistry from the University of Lausanne. Sebastian has 8 years of background in research, with broad experience in project design and management, as well as data analysis, scientific writing and science communication. At Medidee, he supports you with technical documentation for CE-marking, clinical evaluations for medical devices, performance evaluations for IVDs, as well as related regulatory aspects. Sebastian speaks fluently English and German and has a good understanding of French.

Dr Neeru Mittal

Project Associate

Dr Neeru Mittal is a material scientist with expertise in design, synthesis, and characterization of materials for energy-related applications and has 9 years of research experience in nanotechnology, electrochemistry, analytical chemistry, and polymer chemistry. She obtained her integrated BS-MS degree, with a major in Chemistry from IISER-Mohali, India. Then, she moved from India to Switzerland to pursue her doctoral studies that focused on developing biodegradable batteries for green electronics at ETH Zurich. Over the course of her PhD study, she did an abroad stay in South Korea as a part of the Young Researchers’ Exchange Program, collaborated with scientists around the world, mentored 10+ undergraduate students, and published her research results in many peer-reviewed journals. She has gained extensive experience in scientific writing, project management, technical documentation and risk assessment while working in multiple international laboratories and start-ups. Neeru supports you in several medical device-related topics, such as the evaluation of biological safety of medical devices and the redaction of clinical evaluation reports. She is fluent in English and Hindi.

Zuzana Tumova - Medidee Services

Zuzana Tumova

Services and Training Customer Care Manager

Zuzana Tumova is a professional with 15+ years of experience in training & development, project management, and international relationships. Leveraging her skills in large international companies as well as European-level NPOs, Zuzana also expanded her expertise in quality assurance while managing and developing an accreditation board in respiratory medicine. In addition to her Master's degree in Business and Administration, Zuzana speaks fluent English, Czech, Slovak and French and has a good command of Italian. Zuzana is bringing Medidee's services closer to our clients by managing service requests, training operations, and supporting the European network of CARAQA programs.

Dr Rima Padovani - Medidee Services

Dr Rima Padovani

Senior Consultant

Dr. Rima Padovani is a senior regulatory professional with RAC (Devices) certification and 10+ years of experience in the field of medical devices. She holds a PhD in Microsystems and Microelectronics from EPFL (Switzerland), and a Master of Science degree in Biomedical Engineering from the Polytechnic of Turin (Italy). Her R&D background and passion for innovation enable her to provide in-depth support for D&D, V&V, and Risk Management of medical devices. Rima offers her expertise in defining and implementing strategical regulatory activities for medical devices (including AIMDs, combination products, cardiovascular implants, ATMPs and IVDs) for regulatory approval in Europe and US. She provides support from the early development phase (e.g., regulatory pathway, pre-market clinical strategy, consultation with regulatory authorities) to the post-market phase (e.g., transition to MDR, clinical development plan and PMCF). Rima is fluent in English, French and Italian.

Bruno Strappa - Medidee Services

Bruno Strappa

Project Associate

Bruno holds a M. Sc. in Bioengineering. He manages a portfolio of regulatory compliance projects with both large bio-pharmaceutical firms and medical devices / IVD startups. He has previously worked at a medical device start-up managing an interdisciplinary team, developing the regulatory approach and related Technical Documentation. Bruno has extensive experience in the setup of regulatory strategies and related technical / QMS documentation for EU and US approval, especially for drug device combination and for IVD products where the concepts of scientific validity and analytical performance are central. Bruno is fluent in English and Spanish.

Dr Antònia Banús - Medidee Services

Dr Antònia Banús

Project Associate

Dr. Antònia Banús is a biotechnologist by training and holds a Ph.D. in biomedicine. She has more than 5 years of professional experience in the field of translational research, with a main focus on immunology and oncology. Dr. Banús also has a solid background in molecular biology and animal experimentation, as well as experience in the Biotech industry, where she has coordinated medical device and toxicokinetic pre-clinical studies with large animals in a GLP environment. Her educational background and proven scientific writing skills, completed by her formal education and experience in managing interdisciplinary projects, are main assets for the support of your pre-clinical projects under consideration of all quality and regulatory requirements. Dr. Banús is ready to support you with clinical evaluations, biological risk assessments and with the design of pre-clinical studies. She is fluent in English, Spanish and Catalan.

Joana Gomes - Medidee Services

Joana Gomes

Marketing & Communication Manager

Joana Gomes is a Marketing and Communications professional with 5+ years of experience, particularly in the field of B2B biotechnology products and services. With a Master's Degree in International Management and strong intercultural communication skills, she has conducted marketing and consumer research in Europe and Asia, which enables her to tailor messages to different target groups effectively. Joana brings Medidee’s services closer to you, by making sure we provide relevant content, materials and trainings to professionals in the industry. She speaks fluent English, Portuguese and Spanish and has intermediate knowledge of French, German and Mandarin Chinese.

Dr Núria Gresa

Project Associate

Dr Núria Gresa a biologist by training and holds a PhD in Biomedicine. She has 10 years of experience in neuroscience and cellular biology research. She has a strong background in clinical and translational research acquired as a postdoc in Hospital Clinic in Barcelona, and in animal models gained in a postdoc at Karolinska Institute in Sweden. During her career she participated at international conferences with oral presentations and published her work in top peer-reviewed journals. Before joining Medidee she worked as an assistant lecturer professor at University Pompeu Fabra in Barcelona, developing strong skills to communicate complex concepts in a simple and approachable way. She has strong competence in clinical investigation, medical writing, data management and statistical analysis. Núria is fluent in English, Spanish and Catalan, with good understanding of French and Italian.

Dr Laia Morato - Medidee Services

Dr Laia Morató

Project Associate

Dr Laia Morató is a biologist by training and holds a MSc in neuroscience and a PhD in Biomedicine from the University of Barcelona. Laia continued her academic career as a postdoctoral fellow at the Swiss Federal Institute of Technology in Lausanne (EPFL). She has more than 10 years of professional experience in neuroscience and metabolic research, with a strong expertise in molecular biology and animal experimentation, and a solid understanding of diagnostic and therapeutic solutions for metabolic, neurodegenerative, and mental disorders. During her academic trajectory, she has also developed strong competencies in scientific writing, data and project management, as well as statistical analysis. Laia has published her work in prestigious peer-reviewed journals and presented at various international conferences. She is ready to support you with (pre-) clinical evaluations and review of technical documentation. Laia speaks fluently English, Spanish and Catalan and has a good understanding of French.

Paige Elizabeth Sutton

Paige Elizabeth Sutton

Project Associate

Paige is a Quality Management and Regulatory professional with 10 years track record in the medical device industry. Her expertise includes product design and development, process validations, V&V, complaint handling, QC strategies, QMSdeployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced in maintaining QMS certification and FDA approvals for invasive and implantable products such as surgical spinal and orthopedic implant systems, products with neurological applications, and also textile products. Paige holds a BSc in Material Science and Engineering from Lehigh University (PA), is Lean Six Sigma Black Belt, and ASQ certified as a Certified Quality Engineer. Also, Paige is certified as a NAMSA Regulatory Toxicology specialist. Paige assists clients with product design and development of upper-classes medical devices, complex process control, and deployment/maintenance of QMS, including execution of audits and suppliers follow-up.

Stivani Peto - Medidee Services

Stivani Peto

Project Associate

Stivani holds a MSc in Medicine with Industrial Specialisation from Aalborg University and is specialized in Medical Market Access. Stivani has experienced in project management and is proficient in scientific writing. She is also supporting Medidee clients with Quality Management System deployment, assembly of technical files with a focus on usability. She also supports projects with health technology assessment and ethical aspects of clinical research. Thanks to her Medicine with Industrial Specialisation she has an understanding of anatomy, physiology, general pathology, and pharmacology. With her academic background Stivani is ready to support you in regulatory aspects and quality assurance. Stivani speaks fluently English, Danish and Assyrian Neo-Aramaic.

Anna Amovilli - Medidee Services

Anna Amovilli

Project Associate

Anna holds a M.Sc. in Biomedical Engineering from Politecnico di Milano and is specialized in Biomechanics and Biomaterials. Prior to joining Medidee, Anna worked in the research and development team of the University Hospital of Basel towards the clinical translation of bioreactor-generated tissue-engineered products.
With her academic background and professional experience, Anna supports you in setting up, conducting, monitoring and reporting clinical investigations. She is experienced with MDR-compliant technical documentation, QMS deployment and maintenance, as well as FDA 510(k) submission. Additionally, she supports clients to comply with EC/CH-REP obligations. Anna speaks fluently English and Italian.

Medidee team member - Dr. Lydie Moreau

Dr Lydie Moreau

Project Associate

Dr Lydie Moreau is a biologist by training and holds a Ph.D. in food science and nutrition. She has a proven record of more than 15 years managing international projects in industry and academia. Lydie has experience in product development all the way from design to industrialisation. She then has successfully supported the research and development teams worldwide from a regulatory point of view to ensure compliance by design. This background gives her a solid understanding of the product development stages and the associated regulatory framework. Lydie has recently completed her Certificate of Advanced Studies for Regulatory, Quality and Clinical Affairs applied to medical devices. She is fluent in French and English.

Olivier Gschwend - Medidee Services

Dr Olivier Gschwend

Project Associate

Olivier Gschwend provides Clinical and Regulatory support related to Medical Devices and In Vitro Diagnostic devices. His expertise, among others, covers clinical evaluation, clinical investigations, clinical strategy, scientific writing, statistics, and management of multidisciplinary projects. Olivier is a trained medical biologist PhD. He has more than 10 years of professional experience in neuroscience research and his work has been published in top-ranked journals. With his deep knowledge of state-of-the-art electrophysiology and imaging neurotechnology, Olivier holds a strong technical expertise in brain implantable devices.

Olivier is fluent in French, English, and German.

Rosalinde Pots - Medidee Services

DR Rosalinde Pots

Project Associate

Dr. Rosalinde Pots is an applied physicist with a passion for medical applications. She was a PhD candidate at the RWTH Aachen and performed her research in the Crystal Clear group at CERN. There she focused on the development of state-of-the-art instrumentation for medical PET scanners, especially concentrating on reaching extremely high time resolution. She has experience working in various interdisciplinary collaborations for the development of the necessary technologies. Rosalinde also contributed to numerous science education, training and outreach activities and has a special interest in helping bridge the R&D to market process of medical devices. She supports you in clinical evaluations, review of technical documentation and regulatory strategies.

Rosalinde speaks English, French and Dutch.

Stefan Staltmayr - Medidee Services

Stefan Staltmayr

Senior Associate

Stefan Staltmayr is an industrial engineer with an electrotechnical background and 9 years of experience within the international medical device industry. As a quality technician for production of medical devices he has gained strong knowledge of QMS according to EN ISO 13485. As one of the contact points for external audits (FDA, ISO, MDSAP, Inmetro) Stefan has experience in communicating with authorities / NBs. Beside the management of external audits Stefan acted as lead auditor for internal and supplier audits. As a product safety engineer for the product safety certification of active and non-active medical devices, Stefan has in-depth experience in preparation and execution of regulatory safety tests and approvals of medical devices and systems in cooperation with external accredited agencies and certification bodies. Due to his work as a product safety engineer Stefan has a profound understanding of IEC 60601 standard series, ISO 14971 risk management aspects, and on IECEE CB-schemes and NRTL test reports approach for medical devices. Stefan is fluent in German and English.

Giovanni Ria - Medidee Services

Giovanni Ria

Senior Consultant - Germany

Giovanni Ria holds a master degree in Physics and 20 years of technical and managerial experience in Quality, having worked for primary multinational companies, mainly in the medical device industry. During his career, he has been in charge of customer complaint management, production quality control, quality engineering, global quality system, supplier quality. He is functional in designing, implementing and deploying quality management systems in compliance with ISO 13485, 21 CFR 820, and ISO 9001 for large international organizations, as well as for smaller companies. To support the deployment of MDR / IVDR regulatory constraints, Giovanni is also specialized in the upgrade of QMS to merge concepts such as PMS, economic operators, PRRC, Eudamed. Giovanni supports our Clients in evaluating, designing, and enhancing their Quality processes, documents, organizations and tools, including software and methodologies. He also supports process and product validation, risk management, MSA, auditing.

Milind Raje - Medidee Services

Dr Milind Raje

Senior Consultant - APAC

Dr. Milind Raje has 25 years of experience with market leading medical device companies in Australia, in the development of all stages of medical devices (Cochlear implants, bone conduction devices, defibrillators, CPAP devices). He has held leadership roles in manufacturing, supply chain development and new product introduction of novel class 3 medical devices meeting ISO 13485 and 21 CFR Part 820 standards. Milind has extensive experience in managing technology development and manufacturing projects. Milind is helping clients to determine the most appropriate development and regulatory pathways to bring novel medical devices to global markets. He can also participate in review of design, process development and risk management activities.

Remi Beall - Medidee Services

Rémi Beall

Senior Associate

Rémi holds a Master’s degree in Mechanical Engineering from EPF Lausanne. He has previously worked in consultancy, offering services in Production, Supply Chain and Logistics management. As a project associate, then project manager, his role included activities such as data treatment and analysis and design, development and implementation of tailored digital planification tools as well as digital simulation tools. With his previous company, Rémi has been able to apply his knowledge in a variety of fields including pharmaceutical, chemical, watchmaking, machine and waste management industries. Rémi is fluent in French, English and German.

Valentina Lintas - Medidee Services

Dr Valentina Lintas

Project Associate

Dr. Valentina Lintas is a biomedical engineer by education with a specialization in biomechanics and holds a PhD from the University of Zurich (UZH) with focus on tissue engineering applied to minimally invasive cardiovascular technologies. Before joining Medidee, she worked for a med-tech startup, gaining over 2 years of experience in Regulatory Affairs. Additionally, she completed a CAS CARAQA in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostics. Valentina is eager to provide regulatory and quality support for compliance to European regulations, for the CE marking of medical devices and in vitro diagnostic devices. Valentina speaks fluently English and Italian.

Dr Cornelia List - Medidee Services

Dr Cornelia List

Senior Associate

Dr Cornelia List is a microbiologist by training with 5 years of research experience covering topics in genetics, environmental microbiology and infection biology. Her work has been presented at international conferences and published in peer-reviewed journals. Cornelia gathered her experience during her PhD (Swiss Federal Institute of Technology in Lausanne, EPFL) and during her Master’s study (University of Graz). She acquired experience in quality control in compliance with GMP requirements while working in the pharma industry, holds an apprenticeship as dental assistant and has been working for over 8 years with patients and dentists. Cornelia supports clients to assess the safety and performance of medical devices, including clinical evaluations and biological risk assessments. This includes the evaluation of biological risks to define a test plan and the evaluation of the results (toxicological risk assessment). Furthermore, she specializes in advising clients on additional requirements for substance-based medical devices. This implies the support in the establishment of classification and GSPR 12 documentation. Cornelia is fluent in German and English and has an intermediate level in French.

Alba Gutiérrez - Medidee Services

Alba Gutiérrez

Senior Associate

Alba Gutiérrez is a biomedical engineer specialized in Medical Imaging and 3D modelling. She holds a Master in Life Science and a CAS CARAQA in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics. Alba supports with QMS deployment, maintenance and auditing. Her competencies include project management, deployment of MDR compliant technical documentation, including risk management, usability and design verification, and validation activities for software and hardware medical devices. She is experienced in preparing FDA 510(k) submissions and supports you in planning your regulatory strategy. Alba is fluent in English and Spanish and has a good understanding of French.

Jérôme Randall - Medidee Services

Dr Jérôme Randall

Senior Associate

Jerome Randall is a biochemist by education with >8 years’ experience in neuroscience research with focus on neuronal plasticity. He is an expert in molecular biology, animal experimentation and in-vivo neuroimaging. During his research, he co-authored multiple research articles and scientific reviews published in renown peer reviewed journals. Moreover, he holds a Diploma of Advanced Studies (DAS) in Clinical Trial Management, Good Clinical Practice Implementation and Quality Processes from the University of Geneva. He has strong competence in clinical evaluation, clinical investigation, medical writing, clinical trial applications, safety management, monitoring, data management and statistical analysis, PMS (including PMCF), technical documentation review/implementation and QMS implementation and maintenance.

Jerome is eager to provide regulatory and quality support for compliance to European regulations, for the CE marking of medical devices and in vitro diagnostic devices.

Elena Lucano - Medidee Services

Dr Elena Lucano

Training Manager & Senior Associate

Elena holds a PhD in Electronic Engineer from the University of Rome Sapienza. During her PhD, she carried out her research activities at the Division of Biomedical Physics at the U.S. Food and Drug Administration (FDA) laboratories (OSEL / CDRH).
She initially specialized in electromagnetic compatibility assessment of implantable medical devices with magnetic resonance imaging systems. The experience at the FDA laboratories exposed her to regulatory science oriented to Pre-Market research. She has a versatile experience on modeling and simulations, and conformity testing of medical devices to international standards.
At Medidee, Elena manages projects related to regulatory and quality compliance and is also in charge of the CARAQA training programs running in Yverdon-Les-Bains, Basel, Louvain-La-Neuve and Lübeck.
Elena speaks fluently Italian and English and has good understanding of French.

Adrien Marchand - Medidee Services

Dr Adrien Marchand

Senior Associate

Dr. Marchand has 6 years of experience in research and development in the field of Bioanalytical Chemistry. Adrien holds a Master in Chemistry from the University or Liège and a PhD from the University of Bordeaux. He continued academic research as a Postdoctoral Fellow at ETH Zürich. Thanks to his PhD and Postdoctoral research, Adrien gained experience in bioanalytical chemistry and biophysics.
Adrien supports clients to assess the safety and performance of medical devices, including clinical and biological evaluations. This implies in particular the evaluation of the chemical and biological risks in order to define endpoints to be tested to safely place a product on the market, as well as the evaluation of the results, including toxicological risk assessment. Additionally, he defines regulatory strategies for medical devices and substance-based devices and supports cleaning and sterilization validations.
Adrien speaks fluently French and English.

Soizic Guevera - Medidee Services

Soizic Guevera

Chief Financial Officer

Soizic Guevera has several years of experience in the Swiss banking industry, during which she has worked in many sectors.
Through working for large companies, she had the opportunity to thrive in complex environments and develop a broad vision of company issues. These experiences enabled her to hone a wide range of skills in banking products, treasury management, implementation of reporting and working tools, cross-disciplinary projects, as well as department organization.
At Medidee, Soizic works in the finance and administrative team, ensuring financial and performance reporting to the Senior Management, performing business analysis as well as supporting group administration activities.
Soizic speaks French, English and Spanish

Pierre Geens - Medidee Services

Pierre Geens

Business Development Regulatory, Clinical, Quality – EU

Pierre Geens has 15+ years of experience working in the healthcare industry in the fields of pharmaceuticals, biotechnologies and medical devices. During his career, he has been managing projects for major industry players, with international exposure and responsibilities in various areas, including aseptic manufacturing, process validation, design assurance, strategic master plans and quality systems implementation at the corporate level. He has also developed cross-functional abilities, working for medical device startups, in quality assurance, regulatory and clinical affairs, market access, business development, reimbursement and research and development. Pierre is ready to help clients to determine the most appropriate development and regulatory pathways to bring novel medical devices to global markets. He can also participate in design review and risk management activities, as well as in the implementation and streamlining of quality management systems. Pierre is fluent in English and French.

Gaëlle Diserens - Medide Services

Dr Gaëlle Diserens

Senior Associate

Dr. Gaëlle Diserens works as Clinical, Quality & Regulatory Affairs Consultant, providing services to manufacturers of Medical Devices and In-vitro Diagnostic Devices. Her expertise covers, among others, clinical evaluations, clinical investigations, clinical strategy, technical documentation preparation for CE marking, risk analysis, and strategic planning for regulatory pathways. Gaëlle holds a PhD in biomedical sciences from the University of Bern. She has seven years of experience as research scientist in different academic and industries in Switzerland and in England. Her expertise in clinical affairs and medical imaging was developed during her PhD and post-doctoral positions, when she was working in a clinical environment.
Gaëlle is fluent in French, English and German.

Tim Farley - Medidee Services

Dr Tim Farley

Senior consultant-Switzerland

Tim Farley is a professionally qualified PhD statistician with over 35 years’ experience in clinical and epidemiological research on medical devices, diagnostics, pharmaceutical products and public health interventions. Tim worked for 30 years with the World Health Organization in Geneva as a clinical trials statistician and then as a manager and leader of multi-national research focused on the needs of women and men in developing countries – development of new contraceptive methods, safety of existing methods, and prevention of HIV infection. Since leaving WHO, Tim provides scientific and statistical consulting services to public and private European and international clients on scientific strategy, evidence synthesis, and design, analysis and interpretation of clinical and epidemiological studies. Tim is a Chartered Statistician (Royal Statistical Society, UK) and Chartered Scientist (Science Council, UK).

Cedric Razaname - Medidee Services

Cedric Razaname

Senior Consultant

Cédric holds a Master in Microengineering from EPFL Lausanne. He has previously worked in various companies in manufacturing engineering departments, were he gained experience in manufacturing process validation (IQ, OQ, PQ), preparation of technical documentation for manufacturing process, management of suppliers and testing, data analysis and documentation for new products development. Cédric has successfully conducted difficult projects in the field of medical devices, such as technical file preparation for CE marking, risk management, QMS deployment and regulatory pathway analysis. He is used to work in heavy constraint manufacturing environments and has an extensive experience in manufacturing process validation as well as ISO 13485:2016 QMS and ISO/IEC 27001:2013 ISMS implementation.

Delphine Huser - Medidee Services

Dr Delphine Huser

Senior Associate

Delphine is a regulatory and clinical affairs medical biologist, with a research expertise spanning from fundamental to applied research.
Some of the scopes of Delphine’s activities as a Senior Associate in Regulatory and Clinical Affairs are Clinical investigations for both CE-marked and investigational devices, clinical evaluation reports, realization and improvement of technical files, registration of medical devices and QMS deployment.
Within Medidee, Delphine is responsible for managing the Clinical Investigation services delivery Process and assuring its overall compliance with Good Clinical Practice requirements (ISO 14155 and ICH E6 [R2]) related to quality and regulatory aspects.
Delphine speaks French and English.

Kim Rochat - Medidee Services

Kim Rochat

Senior Partner

Kim Rochat is an experienced Project Manager for multi-national and multi-cultural environments (US, Europe, Maghreb). He has a successful track record in QMS implementation, driving risk management activities, auditing for Medical Device manufacturing (ISO 13485, ISO 14971, MDD & IVD Directives and FDA) and in the CE Marking process, including Technical File compilation and validation activities for products and processes.
Kim holds a MBA in IS Security, a BA in Economy, a CAS in Project Management and a CAS in Medtech Ventures Management. Kim combines medical device experience with a proven expertise in Supply Chain Optimization and implementation of good practices.

Jurjen Zoethout - Medidee Services

Dr Jurjen Zoethout

Chief Operating Officer

Dr. Jurjen Zoethout has 15+ years of experience working in cross-functional projects in the fields of medical devices (Drug Coated Balloons, Drug-Eluting Stents) and mechatronic applications (Virtual Reality medical training simulators, automated manufacturing, mobile robotics). He has been responsible for international project management (EU, US, JP), defining, developing and implementing clinical trial (CIP, IB, CTA), regulatory (CE), QA (ISO 13485, 21 CFR Part 820) as well as for conducting M&A due diligence. Jurjen is ready to help clients to determine the most appropriate development and regulatory pathways to bring novel medical devices to global markets. He can also participate in design review and risk management activities, interfacing with Notified Bodies and Competent Authorities.

Silvia Anghel, Medidee Medical Services

Dr Silvia Anghel

Associate Director

Silvia Anghel developed a strong scientific research expertise in highly competitive and international laboratories in Canada and Switzerland, performing research in the fields of oncology, metabolism-related disorders, and gastroenterology.
She also acquired an industrial experience by working in different positions in the In Vitro Diagnostics (IVD) industry. Silvia managed various projects, including development, manufacturing, regulatory and quality and gained a valuable overview of the life cycle of a product from its development to its production and commercialization. Silvia is the Head of Medidee's IVD group, overseeing activities related to IVDR transition, and providing Regulatory and Performance Evaluation (PER) strategies. She helps you to determine the most appropriate (and pragmatic) regulatory pathway, to evaluate and improve your Technical Documentation, including evaluation of your analytical and clinical data, to deploy a QSR and/or ISO 13485 certified QMS and finally, she supports you throughout discussions with Competent Authorities and Notified Bodies. Silvia speaks French, English and Romanian.

Eloïse Lovejoy - Medidee Services

Eloïse Lovejoy

Senior Consultant

Eloïse Lovejoy holds an HES Bachelor’s degree in Design and Materials and a Master of Science MSE in Industrial Technologies, with a specialization in the biomedical field. She has worked as regulatory associate for the implementation of the regulatory and quality control processes for a medical device intended for the Southern Hemisphere.
This background gives her a robust foundation and understanding of the operation of medical devices, as well as aspects connected to their development and production. Eloïse coaches QMS and product certification processes. Eloïse is also specialized in US requirements preparing FDA QSR audit.

Jarka Maierova - Medidee Services

Jarka Maierova

Finance & Administration

Jarka Maierova has 10+ years of experience in finance, accounting and administration in services and industrial companies. In Medidee, Jarka takes care of the compliance of business practices as well as of the delivery of services in Eastern Europe. Jarka masters German, Czech, English and Russian languages.

Richard Curno - Medidee Services

Dr Richard Curno

Chief Scientific Officer

Richard Curno has in depth knowledge of regulatory, clinical and quality activities, with extensive experience of bringing medical devices of all classes to market, including strategic regulatory discussions with notified bodies, competent authorities and FDA. At Medidee, Richard takes the lead on clinical and scientific related processes. Clinical process specialities include Clinical Evaluation, Clinical Investigation design, Clinical Development Planning, including PMCF.  Related to Scientific Process within Medidee, this includes specialisation in biological evaluation and biological safety assessment, assessment of substance-based devices according to GSPR 12, cleaning validation, sterilisation validation, processing validation, together with the design of usability and animal study design as part of V&V activities. Richard is fluent in English and French.

Arthur Goddard - Medidee Services

Arthur Goddard

Senior Consultant USA

Arthur is a RA/QA professional in the medical device industry since over 36 years. His expertise includes: research, product development, manufacturing, servicing, QC and direct administrative supervision. R&D experience includes obtaining FDA approvals for a large variety of devices and achieving ISO 13485 certification to obtain CE Marking, audited to ISO /GMP regulations, hosted FDA inspections; assisted in design / redesign projects.
Arthur holds a BA degree and is Regulatory Affairs Certified (RAC). He is experienced in photo-therapy equipment, minimally invasive surgical devices, dental cement, liquid bandage, wireless neurological devices, orthopedic surgical devices, in vitro fertilization devices, Class IV laser pain management and therapy equipment, cardio-vascular devices, respiratory devices, and tinnitus masking devices.

Dr Linda Ahnen

Senior Consultant

Linda Ahnen is a physicist by training, specialized in biomedical engineering. Her doctorate at the ETH Zurich was carried out in close cooperation with the University Hospital Zurich, developing a novel near-infrared imaging device to image oxygenation in the brain of preterm infants. Linda is experienced in working, navigating, and managing interdisciplinary projects. She actively collaborates with experts from different fields and possesses proven scientific writing skills. Besides managing the Olten team, Linda supports you in clinical and regulatory strategies, is ready to evaluate and set-upTechnical Documentation, including Clinical Evaluations. Additionally, Linda supports you in set-up, coordination and management of Clinical Investigations and Usability Studies. Linda is fluent in German, English and has intermediate knowledge of Spanish.

Somashekara Koushik Ayalasomayajula - Medidee Services

Somashekara Koushik Ayalasomayajula

Senior Consultant

Somashekara Koushik Ayalasomayajula is a polymer engineer with 4+ years of experience within medical device industry in product development and quality & regulatory affairs. During his early career he focused on vascular/cardiovascular, oncology fields and also worked in projects concentrating on implantable devices, disposables and surgical technologies. With combination of technical background and his experience, Koushik is ready to provide support in trainings related to quality and regulatory affairs, deploying QMS according to ISO 13485, integrate MDSAP, GMP requirements and in the preparation of technical documentation of medical devices for global regulatory submissions (EU, MDSAP, ASEAN, South Korea, Argentina, South Africa and India). Being knowledgeable on IEC 27001 and DVG Act (Germany), Koushik can also support for ISMS implementation and approval of Digital health applications (DiGA). Koushik is fluent in English, Telugu, Hindi and has intermediate knowledge of German.

Michael Maier - Medidee Services

Michael Maier

Senior Partner

Michael Maier has 20+ years of hand on experience within medical device industry in design & development projects, product industrialization and regulatory & quality affairs. Michael is a trained Notified Body auditor for ISO 13485 and MDD with a broad scope of products. He has worked for the notified bodies of DEKRA and KEMA and covered international compliance programs as CMDCAS, J-PAL, TCP, TGA.
Michael combines sound technological knowledge with global regulatory expertise in medical devices. Michael holds an MBA in corporate management, a master in Medical Engineering and a Swiss Certificate of Capacity as precision mechanic. Regularly, he is speaker in international events for medical devices, quality and regulatory affairs topics.

Julianne Bobela - Medidee Services

Dr Julianne Bobela

Senior Associate

Dr. Julianne Bobela is a Life Scientist, qualified by more than ten years of professional experience in the field of translational research applied to Neuroscience with a main focus on the development of gene therapy approaches for the Central Nervous System. Her educational background and proven scientific writing skills, completed by her formal education and experience in managing interdisciplinary projects, are main assets for the support of your projects under consideration of all quality and regulatory requirements. Dr. Bobela can assist in the implementation of clinical strategies to support device compliance towards regulatory requirements. Her expertise includes conducting clinical evaluations for medical devices and performance evaluation for IVDs. She is also an active member of the Medidee clinical team, supporting the setup, management and final analysis of clinical studies on medical devices, including IVDs.

Julianne is fluent in French, German and English.