Equipe

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.

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.

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.

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

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.

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

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

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

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

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 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.

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 4+ years of experience in the MedTech industry. In previous international medical device companies, his primary missions were to lead Regulatory Affairs activities to comply with international regulations and standards and lead global registrations and submissions. He supported design and development activities, including verification and validation, risk management, usability, vigilance, complaint handling, and ongoing improvement and change management processes. Itamar provides regulatory support as part of the US and the EU markets' pre-approval process with deep knowledge and experience of MDSAP and other selected Asia, South America, Middle-East countries-specific regulations, and registration process. He provides initial implementation, maintenance, audit, and update of the QMS against ISO 13485, MDR, IVDR, MDSAP, QSR applicable requirements. Itamar speaks fluently English and Hebrew.

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.

ADRIEN MARCHAND

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 Guevera

Senior Finance Associate

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

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

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 decided to expand her expertise in regulatory affairs and quality assurance in Medical Devices at Medidee in 2018 after having acquired her scientific expertise in the field of biomedical and bioengineering over more than eight years in different interdisciplinary laboratories at EPFL. Her main activities as a Senior Associate at Medidee are mainly focused on Clinical Affairs, including writing, reviewing and giving strategical support of Clinical Evaluation Plan (CEP) and Report (CER), Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities, preparation of clinical trial application files for both CE-marked and investigational medical devices, and Advanced Therapeutic Medicinal Products (ATMP), and clinical monitoring activities. Dr Tanja Hausherr also supports her clients in the implementation and review of Technical Documentation under MDD/MDR and IVDD/IVDR, as well as of 510(k) premarket notification for the US market,  and in the deployment of QMS ISO 13485. Next to her strategical support to clients, Dr Tanja Hausherr is part of the Clinical Evaluation Subject Matter Expert group at Medidee. 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 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

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.

Dr Richard Curno

Senior Associate

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.

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.

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

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. Besides managing the Olten team, Linda is specialized in working in 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 and English and has a very good understanding of Spanish.

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.

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 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

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

Quality Manager and Senior Associate

Amalia possesses a broad set of hands-on skills in the product lifecycle from planning a project, down to R&D, testing, and manufacturing. She has 10+ years of multidisciplinary experience (active implantable medical devices, orthopaedics, heart valves, medical imaging, surgical robotics, MRI analysis for Neurorehabilitation, assistive technologies and IoT) and her main expertise lays within Risk Management, Verification & Validation, Production Control, Supplier Management, Corrective & Preventive Actions, Internal and Supplier AuditsAmalia supports clients with restructure of entire QMS for compliance, ISO 13485:2016 certification issuance and renewal, compilation of Risk Management File, Product Specs and V&V testing for Technical Documentation submission of Corrective Action Plans to Notified Bodies (follow-up activities and CAPA closure)implementation of Design & Development and Risk Management activities, performance of internal and supplier audits (certified Lead Auditor), manufacturing of active implants (assembly, injection moulding, welding, cleaning, packaging), delivery of training for awareness and implementation. 

Julianne Bobela-Medidee services team

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.
Julianne is fluent in French, German and English.