Nos services couvrent toutes les étapes du développement produit, depuis l’idée initiale jusqu’à la certification ou l’autorisation d’accès au marché.

Avec des sites en Suisse, Allemagne, Danemark, Belgique, USA et APAC, Medidee est un fournisseur global soutenant des entreprises et organisations de toutes tailles allant de la PME à la multi-nationale.

Medidee a été fondée par trois partenaires, tous experts dans le domaine des dispositifs médicaux et de l’IVD. En tant que professionnels multidisciplinaires nous offrons les compétences pour prendre en charge votre projet sur tout son cycle de vie. Notre équipe se développe régulièrement pour fournir les meilleures compétences au travers des étapes les plus exigeantes de votre projet.

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.

Ramanil Perera - Medidee Services

Dr Ramanil Perera

Project Associate

Ramanil holds a PhD from the ETH Zurich in Cancer Biology. She has experience working in academia, the pharmaceutical and diagnostic industry, as well as a medical device start-up, where she was involved in various activities in IVD development. She has considerable experience working on different research projects in various topics, which helps her assist and navigate diverse clients with ease. She is proficient in scientific writing and communication and she is ready to support you in clinical evaluation and investigation. She is fluent in English and has a good understanding of German.

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. Anna conducted her master thesis on the qualification of a bioreactor system, supporting the research and development team of the University Hospital of Basel towards the clinical translation of bioreactor-generated tissue-engineered products. She acquired experience in product design and development, technical documentation and planning of qualification activities with a risk-based approach, to ultimately ensure compliance to GMP requirements. With her academic background and professional experience, Anna is ready to support you in regulatory and quality aspects related to product design, development, and clinical application. Anna speaks fluently English and Italian.

Tamara Lewis - Medidee

Tamara Lewis

Senior Associate

Tamara is a Quality Management and Regulatory professional with 18 years experience in the medical device industry. Her expertise includes product design and development, risk management, servicing and installation, manufacturing, process validations, design verification and validation, Quality Control, Quality Management System deployment, and auditing to ISO 13485 and FDA 21 CFR Parts 210, 211 & 820. She is experienced in obtaining ISO 13485 certification and FDA approvals for invasive and implantable products such as surgical spinal and orthopedic implant systems, products with neurological applications, minimally invasive surgical instruments, and sterile container systems. Tamara holds a BA degree in Law, is ASQ certification as a Certified Quality Manager/Operational Excellence and is certified as a NAMSA Biocompatibility Specialist. Tamara is looking forward to assisting with product design and development of Class II and Class III medical devices, combination products, active medical devices and deployment of Quality Management Systems.

Gustavo Hernandez - Medidee services

Dr Gustavo Hernandez

Project Associate

Dr. Gustavo Hernández is an engineer and holds a Phd in AI applied to healthcare. He has been working in more than 10 European projects as software developer and technical coordinator. Gustavo has a strong background and experience in academia and research on diverse topics associated with ML/DL algorithms and technological systems. He is experienced in multi-disciplinary work, including skills to cope with the specific needs of target users and taking into consideration the procedures towards the validation and verification of ICT solutions in the scope of healthcare. With his academic background and his experience in several projects Gustavo is ready to support your software project from the regulatory and clinical site. He is fluent in Spanish and English.

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.

Stamatia Pagoulatou - Project associate at Medidee

Dr Stamatia Pagoulatou

Project Associate

Dr. Stamatia Pagoulatou is a mechanical engineer and has 5 years of research experience in the field of hemodynamics and cardiovascular technology. She completed her PhD at the Swiss Federal Institute of Technology in Lausanne (EPFL), where her primary research focus was the design, development and validation of software for cardiovascular monitoring, as well as the organization and execution of clinical studies. She has expertise in data analysis, digital simulation tools and profound understanding of current diagnostic and therapeutic solutions for cardiovascular patients. In the context of her PhD, she presented her work at various international conferences and published in peer-reviewed journals. Her competences include clinical evaluations, project management, data analysis comprising machine learning approaches, and scientific writing. Stamatia is fluent in English, French and Greek, and has an advanced level of Spanish and German.

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.

Ana Campillo - Medidee Services

Dr Ana Campillo

Project Associate

Ana has a solid background leading the trial design of international retrospective/prospective multi-centric clinical studies, the development of clinical documents and study reports for medical devices and IVDs. She also has experience in the operational aspects of clinical study management. Ana has proven success in handling regulatory frameworks, including leading several submissions to Ethical Committees as well as a good understanding of ICH-GCP guidelines, standards (ISO 14155:2020, ISO 20916:2019) and FDA requirements (BIMO). At Medidee, Ana supports you in clinical evaluations and clinical investigations with a particular focus on IVDs. Ana is fluent in English, Spanish and Catalan and has good understanding of French.

Rosalinde Pots - Medidee Services

Rosalinde Pots

Project Associate

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.

Simone Musiu - Medidee Services

Dr Simone Musiu

Project Associate

Simone Musiu holds a PhD in Biomedical Science from the Catholic University of Leuven where he developed a strong scientific expertise in the fields of immunology, microbiology, and antiviral drug discovery.
He also has 5 years of industrial experience with the development of In Vitro Diagnostic Medical Devices (IVD). Simone managed numerous projects related to the IVD development, bringing products from development to industrialization. As such, Simone has a solid expertise in implementing Design & Development activities compliant with ISO13485 requirements that includes design control, risk management, verification and validation, and finally the preparation of the Technical Documentation according to the IVDR requirements. During his career, he has gained a strong expertise in cutting-edge research, strategic planning, as well as project management, leading and managing wide international cross-functional teams to develop IVD products for global launch.
Simone is ready to assist you with the evaluation and implementation of your Technical Documentation, including evaluation of your scientific and clinical data, to provide you support during the Design & Development process, and finally to support the implementation and/or management of QMS based on ISO 13485. Simone speaks fluently Italian and English and has a good understanding of French.

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

Project 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.

Manak Shah - Medidee Services

Manak Shah

Project Associate

Manak Shah holds a Master in Biomedical Engineering and is very experienced with MedTech consulting. He worked on multiple quality management and regulatory affairs projects for MedTech and Pharma companies. With his gathered knowledge and experience Manak supports our clients within MDR transition projects, clinical trials regulation, computer system validation and execution of audits according to the currently applicable standards & regulation. With his training and experience as Scrum Master and his understanding of software development processes and related international guidance documents from FDA, CFDA and standards (e.g. EN ISO 62304, AAMI TIR 45), he perfectly supports the implementation of a QMS including an agile software development process. Furthermore, he is in position to guide and support the registration process of medical device including Digital Health. Manak is business fluent in 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

Project Associate

Dr. Cornelia List is a microbiologist by training with 5 years of research experience, covering topics in genetics, environmental microbiology and infection biology. Cornelia gathered her experience during her PhD at the Swiss Federal Institute of Technology in Lausanne (EPFL) and during her Master's study at the University of Graz. She participated at international conferences with oral presentations and published her work in peer-reviewed journals. She acquired experience in quality control in compliance with GMP requirements while working in the pharma industry. She holds an apprenticeship as dental assistant and has been working over 8 years with patients and dentists. Cornelia supports you in clinical evaluations and review of technical documentation with a particular focus on microbiological requirements for medical devices. Cornelia is fluent in German and English and has an advanced level in French.

Léa Jamelot - Medidee Services

Léa Jamelot

Brand & Communication Manager

Léa Jamelot acquired a strong marketing knowledge at Rennes School of Business. With a Master in Management and a Master of Science in Project Management, she worked with several companies, allowing them to gain in popularity thanks to her work on their websites, social medias, communication and services. At MedideeLéa is in charge of Medidee’s brand communication and of the operation of the trainings & events agenda. She also works along with Philippe Etter and Dr Elena Lucano in the operations of CARAQA training programs running in Yverdon-Les-Bains, Basel, and Louvain-La-NeuveLéa is fluent in French, English and Spanish.  

Alba Gutiérrez - Medidee Services

Alba Gutiérrez

Project Associate

Alba Gutiérrez is a biomedical engineer specialized in Medical Imaging and 3D modelling. During her master’s studies in Life Science, Alba conducted her thesis on the regulatory strategy and gap analysis between the MDD (93/42/EEC) and the new MDR (2017/745). She successfully completed the CAS CARAQA in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostics. Leveraging her technical background and expertise, Alba is ready to support you in the fields of quality management systems, regulatory affairs and US market access. Alba is fluent in English and Spanish and has a good understanding of French.

Eric Santos - Medidee Services

Eric Santos

Senior Consultant - APAC

Eric Santos has 19 years of experience in Testing, Inspection and Certification business, with mid-level management position including local QM and HSE Officer to lead activities in compliance with global certification initiatives and quality assurance related task. He is currently employed as a Managing Partner in Asia Pacific Region based in the Philippines. In previous work experience as Notified Body Auditor, his major responsibility is to carry out document review, audit planning, report preparation and project management. Including review of technical file, review of conformity assessment route, medical device classification, post market surveillance in compliance with international regulation and standard. Eric is fluent in English and Tagalog.

Dr Kasia Jagielska - Medidee Services

Dr Kasia Jagielska

Project Associate

Kasia Jagielska is a life scientist with academic background is in the field of biotechnology and immunology. Kasia has worked in international groups in Poland, Finland, USA and Switzerland what has greatly contributed to her strong communication skills. Her professional activities include development and revision of technical documentation for CE certification, MDR transition, and 510k submission. Kasia specializes in clinical and biological evaluations, PMS/PMCF strategies, regulatory pathways and substance-based product classifications, risk management and V&V activities. She actively collaborates with experts from different fields and has worked on projects concerning devices of different risk classes, including implants, dental products, surgical instruments and active medical devices. Kasia is fluent in Polish and English, with good understanding of German.

Jérôme Randall - Medidee Services

Dr Jérôme Randall

Project 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.

Mohit Kumar - Medidee Services

Dr Mohit Kumar

Senior Associate

Dr. Mohit Kumar is an experienced Biomedical Scientist with >10 years of research experience, acquired at reputed institutions in New Delhi (IN), Heidelberg (DE), Stanford (US), and Basel (CH). At Medidee, he applies his competencies in literature research, scientific writing, computation and analysis while authoring Clinical Evaluation Reports, drawing up strategic plans for market entry (regulatory pathways), advising/guiding clients on the application of ISO 14971, ISO 13485, and IEC 62366 standards to fulfil regulatory requirements of the MDR/IVDR, and preparing Technical Files for CE certification. In addition to supporting clients with MDR/IVDR-related needs, Mohit also advises manufacturers of PPE on the requirements of (EU) 2016/425.
Mohit speaks fluent English, Hindi, and intermediate-level German.

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

Chief Business Officer

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.

Leslie Biston - Medidee Services

Leslie Biston

Senior Associate

Leslie is specialized in maintaining Product Quality, QMS and Regulatory Compliance for medical products. In that respect, she provides a support when it comes to the daily development and maintenance of rigorous quality processes in a dynamic business environment. From a regulatory standpoint, Leslie is systematic and thorough. She masters the parallel setup of regulatory submissions in various regulatory environment while providing continuous support to R&D team or product team for quality aspects. Prior to joining Medidee, she worked in an international medical device company as a product quality engineer, dealing with an intense daily quality control throughput.
Leslie is a skilled computer user. She speaks fluently English, French and has basic knowledge in German.

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 Associate

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.

Karolina Janikowska, Medidee medical devices services

Dr Karolina Janikowska

Senior Associate

Karolina works as Clinical, Quality & Regulatory Affairs Consultant, providing services to manufacturers of Medical Devices and In-vitro Diagnostic Devices. Her expertise covers, among others, medical writing, clinical evaluations, clinical investigations, biological risk assessment, V&V planning and execution (including bench and pre-clinical testing, usability engineering, shelf-life and stability testing), risk analysis, and strategic planning for regulatory pathways.
Karolina speaks English, French, Polish and has a good knowledge of German.

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

Senior Consultant

Silvia Anghel developed a strong scientific expertise of research 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 at 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 Head of Medidee IVD group, overseeing activities related to IVDR transition, providing Regulatory and Performance Evaluation (PER) strategies. She is ready to help 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, to support 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.

Raimo Sump - Medidee Services

Raimo Sump

Site Leader Northern Germany & Scandinavia

Raimo Sump has twenty years of experience developing medical devices in smaller companies as well as globally acting large enterprises.
He has led cross-functional teams to develop devices like soft tissue implants, surgical instruments and auto-injectors for subcutaneous self-injection of large molecule drugs (also known as biologics) from idea screening to successful product launch. His competences include project management, risk management, design reviews, V&V, technical file set-up and QM-System.
Raimo is fluent in English and German.

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.

Sarah El Karmoudi - Medidee Services

Dr Sarah El karmoudi

Senior Associate

Dr Sarah El Karmoudi is a Pharmacist Doctor specialized in medical devices and drug products, particularly in the areas of Regulatory Affairs and Quality Assurance. Sarah has worked in a CRO as a clinical research coordinator in the pneumology and oncohematology areas and, in Laboratoires URGO HEALTHCARE as a Regulatory and CMC Affairs specialist on different class of Medical devices and on OTC drugs. Sarah is ready to support the deployment of quality management systems, facilitating the submission of drug/device combination products, maintenance and establishment of Technical Files and can also assist with clinical evidence generation from concept to commercialization and into post-market activities.
Sarah is fluent in French, English, Arabic and has an intermediate level in Spanish.

Linda Ahnen - Medidee Services

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.

Sanjida Balendran - Medidee Services

Sanjida Balendran

Administrative Assistant

Sanjida Balendran has worked in various corporate environments where she has developed several skills such as multiple-tasking, ability to anticipate needs, respond rapidly to new challenges, and adapt to priorities accordingly. At Medidee Sanjida provides a wide range of administrative tasks related to organization, communication and finance. Sanjida speaks French, German, Tamil and English.

Philippe Etter - Medidee Services

Philippe Etter

Senior Partner

Philippe Etter is active in the field of medical devices compliance since 27 years and one of the three founders of Medidee, the leading MedTech Regulatory, Clinical and Quality consulting firm.
Besides the management of US and Belgium operations, his specialty includes strategic and tactical consulting on regulatory, clinical and quality on critical products such as active medical devices, AIMD, extra corporal circulation, implants and IVD.
Philippe is the founder of the pan-european CARAQA training network training professionals for the MedTech industry in Yverdon -Les-Bains, Basel and Louvain-La-Neuve.
Philippe is fluent in French, English and German.

Moritz Hoyer - Medidee Services

Moritz Hoyer

Site Manager Munich

Moritz Hoyer is multi-role consultant for Quality Management System implementation, process analysis and optimization, industrialization of medical de-vices and registration of active medical devices and substance medical device. He is also an expert for implementing UDI in your company. His profile is rounded by in-depth experience with different technical standards and guide-lines.
One of the specialties of Moritz is to establish customized Quality Manage-ment Systems taking into account economical aspects and company size.
With his technical background and experience in handling regulations, standards and guidelines, he supports the Client by creating the technical file in an optimal way.

Somashekara Koushik Ayalasomayajula - Medidee Services

Somashekara Koushik Ayalasomayajula

Senior Associate

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.