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.

Eric Santos

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.

Monica Albarca

Dr Monica Albarca

Senior Associate

Dr Monica Albarca acquired solid scientific knowledge at the University of Lausanne EPFL, in a multicultural and multidisciplinary environment; and she developed clinical expertise working as a biologist at the Genome Clinique of HUG. Her career began in Quality and Regulatory affairs implementing QMS certification at a software start-up. She deepened her expertise in the In Vitro Diagnostics (IVD) industry in the immunohematology field. She has been responsible for RA, QA & QC departments, and for the deployment and maintenance of QMS under ISO 13485, ISO 15189, ISO 17025 and MDSAP. With her field competence on CE marking and US approval, she supports Medidee Clients towards IVDR transition and first approval of innovative products. Monica also supports innovative companies who first supply their technology as a laboratory service by the means of an accreditation. Her experience as auditor, strategic and tactical consultant allows for a wide range of missions. Monica holds a CAS CARAQA in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostics. Monica is fluent in English, French and Spanish.

Katarzyna Okreglicka

Dr Kasia Jagielska

Project Associate

Kasia Jagielska is a life scientist with more than 8 years of research experience gained in laboratories focusing on structural, molecular, cellular, and in vivo biology. Her academic background is in immune cell development, infectious diseases, cell therapies and innovative gene modification technologies. Kasia worked in international groups in Poland, Finland, USA and Switzerland what has greatly contributed to her strong communication skills. She actively collaborates with experts from different fields and has contributed to several scientific publications. Kasia supports you in clinical evaluations, technical documentation and regulatory
Kasia is fluent in Polish and English, with good understanding of German.

peter sieljacks

Dr Peter Sieljacks

Project Associate

Peter Sieljacks has 5 years of experience in research focusing on various aspects of muscle health and holds a PhD in Health and Life Science. He has successfully managed interdisciplinary clinical trials and published several scientific papers. His competences include project management, clinical trial applications, clinical evaluations, PMS/PMCF, experimental design, analysis, scientific writing and training.
Peter activities in the field of RA, QA and CA cover, clinical evaluations, regulatory strategies and PMS/PMCF.
Peter is fluent in Danish and English

itamar urmann

Itamar Urmann

Project Associate

Itamar Urmann has three years of experience in the medical device industry. He is currently employed as a Project Associate. In previous working places, his primary missions were to lead Regulator Affairs activities to be in compliance with international regulations and standards, global registrations and submissions, support design and development activities, including verification and validation, and to participate in Quality Assurance related tasks.
Itamar is fluent in Hebrew and English.

jerome randall

Dr Jérôme Randall

Project Associate

Jerome Randall is a trained biochemist with >8 years’ experience in neuroscience research. He is an expert in molecular biology, animal experimentation and in-vivo neuroimaging. 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. The latter, coupled with more recent experience in scientific publishing, medical writing, and as Clinical Study Coordinator, has provided him with strong competence in clinical investigation study design, protocol writing, clinical trial applications, safety management, monitoring, data management and statistical analysis, as well as in clinical study publication writing and submission.
Jerome supports principally Belgian clients with their Regulatory strategy and Quality Management System implementation.

mohit kumar

Dr Mohit Kumar

Project 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

Dr Elena Lucano

Training Manager & Project 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 and Louvain-La-Neuve.
Elena speaks fluently Italian and English and has good understanding of French.

ninda syam

Dr Ninda Syam

Project Associate

Dr. Ninda Syam is a clinically oriented scientist with 10+ years of research experience on human disorders in the fields of cancer, cardiology, neurology and in vitro diagnostics. She acquired her expertise at renowned institutes across Europe and Asia in Jakarta, Heidelberg, Bern, Leuven and Bruxelles. As a Project Associate, she applies her competences in scientific writing, experimental design and data analysis to support Medidee's clients in the preparation of Clinical Evaluation Reports and design of clinical investigations, facilitating the submission of technical documentation for CE marking.
Ninda is fluent in English and Indonesian, and she has an advanced knowledge of Malay, an intermediate level of German and Dutch, and a basic level of French.


Dr Adrien Marchand

Project Associate

Dr. Adrien Marchand has 6 years of experience in research and development in the field of Bioanalytical Chemistry. He obtained his Ph.D. thesis at the Interface Chemistry-Biology from the University of Bordeaux, France. His numerous presentations at conferences provided him good scientific communication skills. He also regularly mentored international researchers from different scientific fields and was involved in the writing of multiple scientific publications.
Adrien provides support to assess the safety and performance, incl. biocompatibility, of medical devices. He provides clinical and biological evaluation reports and determines regulatory strategies. This implies the evaluation of the chemical and biological endpoints to be tested in order to place safely a product on the market.
Adrien speaks fluently French and English.

Sonja Horn

Sonja Horn

Project Associate

Sonja Horn has worked as Manager in the Production of IvD under ISO 13485 and 9001. She has also led interdisciplinary working teams for projects, such as introduction of new products. Her academic background as biotechnologist with specialization on bioprocess techniques enables her to understand complex production processes and the interplay with Quality Assurance and other disciplines.
She has a wide knowledge from Risk Management, CAPA, Change Control Processes and UDI implementation to introduction of new products and other production connected topics. Sonja is experienced to implement complex QM systems. Within Medidee Sonja is part of the IVD experts team. Sonja is fluent in German and English but she also has a good level in French.

Soizic Durgniat

Soizic Durgniat

Senior Finance Associate

Soizic Durgniat 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

laurent meuser

Laurent Meuser

Project Associate

Laurent Meuser is a therapeutic technologist with focus on pharmaceutical and medical devices technology as well as pharmaceutical production and analysis.
Since August 2019 he works within Medidee as Quality Affairs and Regulatory Affairs Project Associate with focus on implementation and maintenance of quality management systems according to ISO 13485, as well as technical documentation according to 93/42/EEC and Regulation (EU) 2017/745. During his time with Medidee, Laurent further gained experience in conformity assessment, transport validation, MDSAP requirements, UDI implementation and sterilization procedures.
Laurent is fluent in German, English with knowledge of French and Spanish

Mads Bräuner Madsen

Mads Bräuner Madsen

Project Associate

Mads Bräuner Madsen is educated within the field of medical market access and has worked on projects with both pharmaceutical- and med-ical device companies. Mads has dealt with activities ranging from but not limited to analyzing the buying processes of medical devices in Denmark to compiling market access strategies for health-IT providers. Mads is ready to support you on Regulatory Affairs according to the MDR (2017/745) and the IVDR (2017/746). Furthermore, Mads has gained experience in the implementation and maintenance of Quality Management Systems according to ISO 13485:2016 as well as clinical aspects according to ISO 14155:2020.
Mads is fluent in Danish and English with a good command of German and Norwegian.

Cecile Rod- Medidee medical devices ervices

Cécile Rod

Project Associate

Cécile Rod is a multi-role consultant with a MSc in biomedical engineering from ETHZ and a strong regulatory and clinical background. Cécile has worked as a Clinical Research Associate (CRA) in a CRO and as a biomedical engineer in the largest hospital in Switzerland before moving to the industry where she worked as Medical Development Manager and Clinical Trainer within a start-up company. Cécile has a strong hands-on experience in the regulatory and clinical environment, including but not limited to: project management; MDR transition; risk management; clinical trials management; clinical training; KOL relationship management. She has also established a network of medical professionals with-in various fields such as neurosurgery, ENT, ophthalmology, intensive care and gynaecology.
Cécile is fluent in French and English with good command of Spanish and Ger-man.

Pierre Geens

Pierre Geens

Senior Consultant-Belgium

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.

Zahra Hashemyian-Medidee medical devices services

Dr Zahra Hashemiyan

Project Associate

Zahra Hashemiyan holds a Ph.D. in advanced medical imaging devices, medical Ultrasound, MRI, MRE imaging. Her academic background is in Mechanical/Electrical Engineering with emphasis on sensors in medicine. She has experience in international development project and realization of projects with industry. She is highly skilled in task management, planning of engineering tasks and reporting. She has experience in oral presentations in big international conferences and publishing in well-recognized journals. Zahra is fluent in English and speaks Polish and Persian.

Leslie Biston- Medidee services

Leslie Biston

Project 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.

Tanja Hausherr

Dr Tanja Hausherr

Senior Associate

Dr. Tanja Hausherr is a Bioengineer who expanded her expertise in regulatory affairs and quality assurance in Medical Devices at Medidee after having acquired her scientific expertise in the field of biomedical engineering over more than eight years in different interdisciplinary laboratories at EPFL.
Her main activities are mainly focused on Clinical Evaluation, preparation of clinical protocols and reports for both CE-marked and investigational medical devices and Advanced Therapeutic Medicinal Devices, realization and review of Technical Documentation and 510(k), and deployment of QMS.
Tanja is fluent in French, German, Swiss German and English.

Gaelle Diaserens- medidee service

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

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).

Cédric Razaname

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.

Heiko Baehr

Heiko Bähr

Senior Consultant-Germany

Heiko Bähr has more than 20 years of experience within medical device industry mainly in Product Management (Endoscopy). During his career, he has been managing projects with international exposure and responsibilities in various areas.
He has experience with evaluation of technologies, product roadmaps to ensure strategic competitiveness and innovation, international markets as well as intercultural cooperation in projects and with customers.
He has also developed cross-functional abilities, in global master data management systems, IFU processes, member of complaint-handling and management review board, business development and market access.

Dr Rima Padovani

Senior Associate

Dr. Rima Padovani is a biomedical engineer by education with a specialization in microengineering, focusing on the development of microfluidic platforms for biomedical applications.
Rima is ready to provide regulatory and quality support for compliance to European directives and regulations, for the CE marking of medical devices and in vitro diagnostic devices, including high-risk innovative products such as active implants, high risk IVD, device led-combination products, and cardiovascular implants. Within Medidee Rima is part of the IVD experts team.Rima also provides strategic support in the definition of regulatory pathways for Europe and US. Rima is fluent in English, French and Italian.

Karolina Janikowska- Medidee medical devices services

Dr Karolina Janikowska

Project 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 Medical

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

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

Dr Jurjen Zoethout

Site Manager Switzerland

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 Associate

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 ready to help you to determine the most appropriate regulatory pathway, to evaluate and implement your Technical Documentation, including evaluation of your scientific and clinical data, and finally QMS implementation based on ISO 13485. Within Medidee Silvia is part of the IVD experts team.
Silvia speaks French, English and Romanian.

Eloïse Lovejoy

Eloïse Lovejoy

Senior Associate

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 Maier

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.

Wojciech Bobela

Dr Wojciech Bobela

Senior Associate

Wojciech holds a PhD degree in translational Neuroscience, which he obtained from EPFL. His main areas of expertise cover design and performance of clinical and pre-clinical studies (both in vitro and in vivo); definition of clinical and regulatory strategy; Clinical Evaluations (MEDDEV 2.7/1 rev4 and EU 2017/745); Good Clinical Practices (ISO 14155 and ICH E6 [R2]); sterilization validation and biostatistics. He is an experienced coach and trainer in subjects related to clinical evaluations and sterilization, as well as author/co-author and reviewer of numerous Clinical Evaluations. Within Medidee, Wojciech is responsible for managing the Clinical Evaluation Process, and assuring its overall compliance with state of the art requirements related to quality and regulatory aspects.
Wojciech speaks Polish, English, French and has basic competence in German.

Dr Richard Curno

Senior Associate

Richard Curno is a regulatory affairs and quality assurance-oriented analytical and synthetic chemist, with in-depth knowledge of bringing medical devices, particularly surgically invasive and implantable devices, to market.
One of the specialties of Richard is to organize the clinical evaluations of medical devices, from setting up a clinical investigation, to reporting and documentation in readiness for certification. Other key competencies are biological evaluation and biocompatibility assessment of medical devices, as well as support for cleaning, reprocessing and sterilisation validation of medical devices.
Richard is fluent in English and French.

Wiliam Enns Bray-Medidee services

Dr William Enns-Bray

Senior Associate

Dr. William Enns-Bray’s professional activities include regulatory strategy for medical device market access in both EU and US, performing risk analyses and clinical evaluations, and reviewing technical documentation and quality management systems. He is specialized in compliance of medical device software, including stand-alone software as medical devices, embedded software components, and software using AI/ML based algorithms. William regularly delivers training and workshops on topics covering medical device software classification, software life cycle processes according to IEC 62304, software verification and validation, risk management, cybersecurity, clinical evaluation, and post-market surveillance systems. William has over eight years of combined experience working full time in inter-disciplinary biomechanics research and medical device industry.
William is fluent in English and has working proficiency in German.

sandra klompmaker

Dr Sandra Klompmaker

Senior Associate

Dr. Sandra Klompmaker is an RA/QA and clinical investigations-oriented life scientist with more than 10 years of experience in in vivo and in vitro experimental design, implementation and data analysis.
Sandra's core activities in the field of RA/QA and clinical affairs cover Clinical Evaluations and clinical strategy development, the assessment of the biological safety of medical devices and the deployment of quality management systems. Other key competences are the implementation of PMS and PMCF procedures and the preparation of regulatory pathways. She is ready to train and coach clients on these subjects and handle inter-actions with Notified Bodies and Competent Authorities.
Sandra is fluent in German, English and Dutch, with a basic knowledge of French.

Raimo Sump- Medidee services

Raimo Sump

Senior Consultant-Germany

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

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.

Medidee- Sarah Elkarmoudi

Dr Sarah El karmoudi

Project 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

Dr Linda Ahnen

Senior Associate

Linda Ahnen is a physicist by training. She specialized in biomedical engineering during her Diploma and PhD studies. Her doctorate at the ETH Zurich was carried out in close cooperation with the UniversityHospital Zurich, developing a novel near-infrared imaging device to image oxygenation in the brain of preterm infants. Linda has experience in working and managing interdisciplinary projects, she actively collaborates with experts from different fields and possesses proven scientific writing skills. Linda supports you in clinical evaluations,
clinical investigations, technical documentation, regulatory strategies and implementation of quality management systems.
Linda is fluent in German, English and Spanish.

Sabrina Erne, Medidee, ra qa ca services

Sabrina Erne

Process & Events Associate

Sabrina Erné has worked as a communication and supply chain coordinator in various different medical devices companies.
She developed a wide range of skills by working in start-up companies and fast evolving environments. Sabrina has experience in events organization within international conferences, marketing-communication tools development, Corporate Identity development, customer orders and shipment management as well as Quality Management System maintenance. At Medidee, Sabrina manages training organization and corporate communication. In addition, she also provides support to QMS maintenance and business-related activities. Sabrina speaks French and English.

Sanjida Balendra, 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

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.

Silvia Scarabelli- Medidee services

Dr Silvia Scarabelli

Project Associate

Dr. Silvia Scarabelli is a Biochemist with more than 7 years of research experience in the fields of chemistry and molecular biology. Within Medidee, Silvia is part of the IVD experts team. Her expertise covers, among others: clinical evaluations for MD, performance evaluation for IVD, clinical investigation project management, communication with regulatory and competent authorities, clinical affairs for software standalone as MD, Technical Documentation set-up for CE marking of MD and IVD, implementation and maintenance of ISO 13485-compliant QMS, risk analysis and strategic planning for regulatory pathways.
Silvia speaks fluently English, French and Italian.

moritz hoyer

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.

Koushik Ayalasomayajula- medidee services

Somashekara Koushik Ayalasomayajula

Senior Associate

Somashekara Koushik Ayalasomayajula is a QA&RA and process consult-ant with 4+ years of experience in medical devices field. His knowledge on statistics and 6 methodologies enables him to serve clients during their product development, optimization of the production process and process validations. With combination of technical background and his experience, Koushik is ready to provide support in the deployment of QMS according to ISO 13485, integrate MDSAP, IEC 27001, ISO 14001 requirements and in the preparation of technical documentation of medical devices for approval in various world mar-kets.
Koushik is fluent in English, Telugu, Hindi and has intermediate knowledge of German.

Edouard Paray

Edouard Paray

Project Associate

Edouard Paray is a biomedical engineer. He has 7+ years of experience in Quality Assurance and Regulatory Affairs in the medical device industry. He worked in various companies including a startup company developing an innovative active implantable medical device in the field of vision restoration, and a global company in the field of surgical tools.
Edouard is ready to provide support in these following fields of expertise: quality management systems implementation, assembly and review of technical documentation, qualification of process equipment, supplier management, nonconformities and CAPA management. Edouard is trained as ISO 13485:2016 auditor and can lead internal and supplier audits, as well as provide support during notified bodies audits. Edouard is fluent in French and English.

michael maier

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.

Amalia Tsanka-medidee services

Dr Amalia Tsanaka

Senior Associate

Amalia possesses a broad set of skills in the product lifecycle from planning a project, down to R&D, testing, and manufacturing. Her main expertise lays within Risk Management, Corrective & Preventive Actions, Internal and Supplier Audits, Production Control, Supplier Management, Verification & Validation.
She has successfully formed and maintained full ISO13485 Quality Management Systems, as well as Medical Device File submissions for clinical trials and CE marking.
She has worked in several projects including active implantable medical devices, orthopaedics, medical imaging, MRI analysis for Neurorehabilitation, assistive technologies and IoT.

Julianne Bobela-Medidee services team

Dr Julianne Bobela

Project 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.
Julianne is fluent in French, German and English.