Neville Rhodes
Quality & Regulatory Affairs Manager
Neville Rhodes is an Analytical Chemist by training and holds an MBA. He has more than a decade of experience at the senior executive level in the chemical, coatings, and automotive industries. Additionally, he completed a CAS CARAQA in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostics. He offers client support across various areas, including project management, regulatory strategy development, QMS maintenance, usability engineering practices, and preparing and reviewing technical documentation for regulatory submissions. Neville is proficient in English and possesses an intermediate level of proficiency in German.
Simone Rumac
Project Associate
Simone Rumac is a biomedical engineer (M.Sc. from the Polytechnique of Turin) with expertise in medical imaging and signal processing, advanced optimization, image reconstruction algorithms, and Machine Learning (ML). He specialized in the field of MRI physics, image acquisition and simulation frameworks in hospital settings, having worked at the Lausanne University Hospital (CHUV). He has also worked on speech-to-text technologies and ML as a software developer. Simone provides support on the regulatory aspects of medical device software, including its development in compliance with IEC 62304, validation of AI/ML-enabled medical devices, and clinical evaluation of Software as a Medical Device (SaMD). Simone is fluent in English and Italian.
Sara Morera Roca
Project Associate
Sara holds a Master’s in Biomedical Engineering from the University of Barcelona and the Polytechnical University of Catalonia. She has previously worked in various companies in design and engineering departments, where she gained experience in custom-made devices (prostheses and jigs) and serial production of implantable devices and single-use related instrumentation. She has experience working alongside surgeons and in usability engineering testing. Sara supports you in manufacturing process validation (IQ, OQ, PQ), preparation of technical documentation, management of suppliers and testing, and documentation for new product development. She has successfully conducted projects in the field of medical devices, such as technical file preparation for CE marking, risk management, QMS deployment and regulatory pathway analysis. Sara is fluent in English, Spanish and Catalan.
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.
Dr Jérôme Randall
Senior Associate
Jerome Randall is a biochemist by education with >8 years’ experience in neuroscience research with focus on neuronal plasticity. He is an expert in molecular biology, animal experimentation and in-vivo neuroimaging. During his research, he co-authored multiple research articles and scientific reviews published in renown peer reviewed journals. Moreover, he holds a Diploma of Advanced Studies (DAS) in Clinical Trial Management, Good Clinical Practice Implementation and Quality Processes from the University of Geneva. He has strong competence in clinical evaluation, clinical investigation, medical writing, clinical trial applications, safety management, monitoring, data management and statistical analysis, PMS (including PMCF), technical documentation review/implementation and QMS implementation and maintenance.
Jerome is eager to provide regulatory and quality support for compliance to European regulations, for the CE marking of medical devices and in vitro diagnostic devices.
Cedric Razaname
Senior Consultant
Cédric holds a Master in Microengineering from EPFL Lausanne. He has previously worked in various companies in manufacturing engineering departments, were he gained experience in manufacturing process validation (IQ, OQ, PQ), preparation of technical documentation for manufacturing process, management of suppliers and testing, data analysis and documentation for new products development. Cédric has successfully conducted difficult projects in the field of medical devices, such as technical file preparation for CE marking, risk management, QMS deployment and regulatory pathway analysis. He is used to work in heavy constraint manufacturing environments and has an extensive experience in manufacturing process validation as well as ISO 13485:2016 QMS and ISO/IEC 27001:2013 ISMS implementation.
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.