Ida previous experience in the quality and regulatory affairs specially in post market vigilance and incidence reporting to National Competent Authorities in Denmark. As well as organizing structed procedures for archiving and documenting customers safety advisory notices according to internal business plans.
Ida is fluent in English and Danish.
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.
Rita Cortvrindt holds Master degrees in Science / Biology and Medical and Pharmaceutical Research. She worked for 20 years in Pathology, Biochemistry and Reproductive medicine. She founded a spin-off CRO and acquired skills in business administration and the implementation of quality management systems.
The last 15 years she worked for the pharmaceutical, chemical and medical device industry, and remained actively supporting authorities for the promotion of the 3Rs and the validation of in vitro bioassays for toxicological assessments.
Rita is a European Registered Toxicologist (ERT), with profound knowledge of reproductive toxicology, endocrine disruption and in vitro toxicology and is a certified auditor at BELAC. She can manage product development and valorization projects, perform toxicological assessments and support the implementation and streamlining of QMS. Rita is fluent in English and Dutch.
Koushik holds a Master in Polymer Technology from FH Aalen, Germany. He has 2 years of experience, working in cross functional teams dedicated towards development and quality control of medical devices. With his technical expertise, he is ready to support clients with shelf life studies, packaging development, process validation (IQ, OQ, PQ) and data analysis.
Koushik is fluent in English, Telugu, Hindi and has intermediate knowledge of German.
Delphine is a regulatory and clinical affairs medical biologist, with the research expertize spanning from fundamental (electrophysiology and biochemistry), to applied research (clinical studies). Some of the scopes of Delphine’s activities as a Project Associate in Regulatory and Clinical Affairs are Clinical Evaluation Reports of medical devices, Biological Risk Assessments, Ethical Committee and Swissmedic submissions.
Delphine leads technical file restructuring projects as well as MEDDEV 2.7/2 Rev.4 CER development.
Delphine Speaks French and English.
Wojciech Bobela has acquired his scientific expertize by being part of competitive and multi-international research teams for almost a decade. He is an expert in in vitro cell technologies, animal experimentation and neuroprotective therapies for Parkinson’s disease. His research expertize serves as an invaluable advantage for anyone willing to establish quality management systems or discuss the application of regulatory legislation to their medical devices.
Wojciech is very experienced in sterilization validation and CER development as per MEDDEV 2.7/1 Rev. 4.
Wojciech obtained his MSc in Medical Biotechnology from Jagiellonian University in Cracow and holds PhD degree in Neuroscience from EPFL in Lausanne. He speaks Polish, English, French and German.
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.
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.
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.
Silvia Scarabelli is a Biochemist with more than 7 years of research experience in the fields of applied chemistry and molecular biology acquired in many internationally renowned universities. She obtained her PhD from EPFL, where she managed a project in partnership with a major Swiss Pharma company aiming at developing innovative biosensors for the assessment of the cellular permeability of small-molecule therapeutic leads.
Silvia speaks fluently English, French and Italian.
Aya Makki holds a BSc in Pharmacy and a MSc in Bio- and Pharmaceutical analysis. Aya has work experience with international GMP regulations, with QC of pharmaceutical products and qualification of process equipment in pharmaceutical manufacturing including the handling of OOS products and the subsequent root cause analysis and CAPA.
Aya coaches QMS implementation and the compilation of technical documentation for conformity assessment procedures especially when the medical devices involve manufacturing processes known from pharmaceuticals.
Yann Cailler has worked in the quality and regulatory field for various startups in traumatology and cardiology, covering all steps from R&D to after sale services.
Yann holds a Bachelor from the University of Applied Sciences Western Switzerland in Microengineering. Yann is a trained auditor for QMS and sterilization services.
With the combination of his technical background and his project management skills, Yann is specialized in understanding complex technical and regulatory environments and is ready to guide you in your certification process from the idea to the marketed product.
Leslie holds a Bachelor of Science in Industrial Design Engineering from the University of Applied Sciences Western Switzerland. Her Bachelor project in the Medical Device field focused on mechanical solutions on a patient support for a standard medical X-ray device for developing countries.
Leslie is specialized in maintaining Product Quality, QMS and Regulatory Compliance for medical products. She provides a great support when it comes to the daily development and maintenance of rigorous processes in a dynamic business environment.
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
Leslie speaks fluently French and English and has good understanding of German.
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.
Jérémie Emery holds a master in Bioengineering from EPFL with an orientation in Biomedical Technologies. He worked 5+ years in IVD companies where he was involved in the development of molecular tests and immunoassays. In the recent years, Jérémie developed his skills in Quality Assurance by supporting start-up companies with the set-up and maintenance of their QMS. He complemented his experience with a CAS in Quality Assurance, Regulatory and Clinical Affairs, and a PMP certification.
Oriented towards Quality Assurance and Regulatory Affairs, Jérémie is ready to support you from the implementation to the audit of your QMS. He will also help you identifying the regulatory requirements for your medical devices and coach you with the set-up of the technical documentation.
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.
Jehan Cellier adds extensive program management experience to his expertise of product and process development in the medical device field. Built on his mechanical & thermal engineering background, during these last 10 years, he has taken the responsibility of a wide range of implant, AIMD and active devices development projects. In this framework he is used to setup robust and validated processes in close contact with product engineers. Within Medidee, Jehan is in charge of business development in key European countries where Medidee is establishing presence. Jehan is your entry contact point for translating your requirement into a project and for dimensionning clinical, regulatory or quality support
Moritz Hoyer leads the Medidee office in Munich, Germany. Moritz has 6 years of experience in QMS & RA. He is in charge of establishing and maintaining QMS according to ISO13485 and coaching development and industrialization of medical devices. Moritz holds a Master in Mechatronics engineering with specialization in medical technologies from the University of Applied Sciences in Munich. With his technical back ground and his experience, Moritz is ready to support and optimize your QMS and to get your medical device cleared in numerous countries.
Cédric holds a Master in Microengineering from EPFL Lausanne. He has previously worked in various companies in the field of the manufacturing engineering, which gives him multiple experiences such as 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 implementation.
Erik Poulsen is a Regulatory Affairs and Quality Assurance specialist with project management and hardware development experience. Before joining Medidee Services Scandinavia, Erik was in charge of quality assurance and regulatory affairs in a Danish wearable medical device company.
Erik’s activities primarily focus on the deployment and audit of QMS, on Technical Documentation setup for active devices, including risk management, usability, and V&V testing.
Erik speaks Danish and English.
Lea Hokland is a human biologist and holds a ph.d. in health science based on implantable, degradable biomaterials and stem cells. She brings experience and lessons learned from 10+ years in human health science, start-up companies and medical device development. Being involved in quality and regulatory compliance for IVD, class III and combination products, Lea has a broad understanding of medical devices – with a particular focus on risk management, usability, and design & development.
Based on her scientific background and experience from clinical environment, Lea also bridges your connection to academia and clinics for thorough clinical evaluations. Lea has profound knowledge on standards and is certified auditor in ISO 13485. Lea is fluent in English and Danish, and has a good command of Norwegian.
Dr Richard Curno is a regulatory affairs and quality assurance-oriented bioanalytical chemist, with in-depth knowledge of bringing a range of medical devices, particularly in the dental and orthopedic field, to market. Richard masters the deployment of the complex manufacturing processes for IVD and medical devices, as well as many aspects of pre-clinical validation, including Biological Evaluation and Biological Risk Analysis according to ISO 10993-1. One of the specialties of Richard is the writing of clinical evaluation, for all classes of medical device, according to MEDDEV 2.7/1 Rev. 4, and also the design of Clinical Investigation and appropriate Post Marketing Surveillance.
Tanja Hausherr is a Bioengieener who acquired her scientific expertise in the biomedical field over the eight past years in different interdisciplinary laboratories at EPFL, where she completed her PhD. During her doctoral studies, she gained expertise in preclinical studies of cell tissue engineering approaches for bone regeneration. She then later broadened her expertise in translational research and developed a human cell banking system.
Her interdisciplinary experiences in project management, supplemented by her excellent active communication with experts of multidisciplinary backgrounds, are her major advantages to support clients in quality management systems, validation processes and regulatory environments for medical devices.
Tanja is fluent in French, Swiss German, German and English.
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.
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 University Hospital Zurich, developing a novel near-infrared imaging device to image oxygenation in the brain of preterm infants. Linda has experience working in interdisciplinary projects, actively collaborates with experts from different fields and possesses proven scientific writing skills.
Linda is fluent in German, English and Spanish
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.
Dr. Sandra Klompmaker is a quality assurance 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. Before joining Medidee, Sandra had been a member of multinational and highly competitive research groups in The Netherlands and Switzerland.
She is ready to support the deployment of quality management systems, facilitating the submission of technical documentation for CE marking of medical devices and eagerly supports clinical evaluations, from the design of the investigation to the final report.
Philippe Etter holds 20+ years of practice in the development and market transfer of medical devices. His experience is built on design, industrialization and CE marking of critical products such as active medical devices, implants and active implants. Having designed more than 44 Quality Management Systems.
Philippe is specialized in accompanying AIMD and IVD projects from A to Z including clinical strategy, investor relationship and leadership coaching. Philippe holds a Master of Science of the EPFL and a European degree III in sterilization of medical devices.
Chloé Fattebert has worked as process engineer in high criticality business domains such as medical devices and transportation. Chloé holds a Bachelor of Science from the University of Applied Sciences of Western Switzerland, in Microtechnical Engineering.
Chloé is heading project teams for multi disciplinary GMP projects and implementation of technical documentation according to best pactices in order to facilitate the regulatory processes. Chloé supports you in getting a medical device CE marked or obtain regulatory clearance under other jurisdictions in various countries.
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).
Giulia Zappacosta is a biomedical engineer by education with research experience in the development of an analytical microfabricated device to characterize single T-cells based on their electrical properties.
Giulia works in interdisciplinary projects and actively collaborate with experts from different backgrounds.
Giulia is ready to provide support on the compilation and review of technical file for CE marking of medical devices and on the preparation of documentation for regulatory affairs submission.
Giulia is fluent in English, French and Italian.
Julianne Bobela is a Life Scientist, qualified by more than ten years of professional experience in the field of translational research. She holds a PhD in Neuroscience, which she obtained from the University of Aix-Marseille II, France. Her doctoral studies consisted of exploring the inflammatory processes associated with the degeneration of motoneurons in Amyotrophic Lateral Sclerosis. Being part of a renowned research team at EPFL, Switzerland, she later gained expertise in the preclinical development of gene therapy approaches for neurodegenerative diseases.
Julianne is highly experienced in cellular and molecular biology as well as in animal experimentation. 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 clinically-oriented projects under consideration of all quality and regulatory requirements.
Julianne is fluent in French, German and English.
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.
William Enns-Bray has 6+ years of experience working full time in the inter-disciplinary field of biomechanics research, investigating mechanics of the knee, hip, and spine. During his career, he has led international research collaborations and has experience interfacing with both engineering and clinical professionals. He is also an accomplished writer and public speaker. Using his skills as a scientist and an engineer, his objective is to assist promoting novel biomedical technologies in modern healthcare systems and facilitate the introduction of these new devices to global markets.
William is fluent in English, and has working proficiency in German.
Dr Rima Padovani is a biomedical engineer and has worked as a scientific researcher in different academic institutions in Dublin, Ireland, and in Lausanne. Rima owns a Ph.D. in Microsystems and Microelectronics from the Ecole Polytechnique Fédérale of Lausanne. She has worked in the development of cutting-edge technologies for biomedical applications.
Rima is specialized in working in multidisciplinary projects, being able to manage different requirements and constraints, and keeping active collaborations with experts from different backgrounds. Rima is ready to provide support on quality assurance and on facilitating the regulatory process of medical devices. Rima is fluent in English, French and Italian. Rima has extensive experience in AIMD pre-clinical and new IVD Regulation.
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. Heiko holds a Master in Medical Engineering.