Do you need to go over your strategic needs?
Secure a free flash meeting sending a request on the partnering platform (opening one month before the event) to meet with one of our experts:
Mrs. Christine GRASSET
Product development, Funding innovation
10 years of experience in R&D, and the management of complex projects with various medical device and cosmetics manufacturers. Working on product development projects as a consultant, Christine oversees the quality/regulatory challenges as well as the strategies to finance innovation.
Mrs. Caroline LÉNÉ
QMS ISO13485, CE-marking, FDA clearance, internal audits
14 years of experience as QA/RA director with various medical device manufacturers. Nowadays consulting with an expertise in electro-medical devices and software medical devices. Assignments vary from setting a quality management system, writing technical dossiers for CE-marking, to international registration filing and internal audits.
Mr. Sébastien FERRET
Clinical evaluation, Risk management, Regulatory strategy, CE-marking
Sébastien is constantly working to help insure the new medical device regulation acts on the performance and safety of medical devices, and not as a burden. Sébastien aims at sharing his experience so that the regulation fits with a company’s strategy along with the marketing message conveyed. The regulatory strategy should allow to bring proof of the performance of one’s device.
Mr. Julien PROUTEAU
QMS ISO13485, CE-marking, Process validation
Julien assists manufacturers in the design, validation and regulation of all medical devices. From design to market launch and post-market monitoring to industrialization, Julien offers his experience and expertise throughout global projects or on specific issues.
Mr. Cyrille MICHAUD
Quality insurance, Regulatory affairs, CE/FDA, Software medical device life cycle management
Cyrille is a consultant specialized in software medical devices, working alongside medical device manufacturers, primarily start-ups. Typical assignments are establishing the proper QA/RA strategy, setting-up a quality management system, processes relative to the life cycle of a medical software, and working on technical files for CE and FDA clearance.
Mrs. Christine HORVAIS
HR audits, Evaluation interviews, Recruitment in Sales-Marketing-QA-RA-Clinical studies-R&D-Top management
After more than 10 years in the healthcare industry, Christine founded AXEME – a human resources company specialized in medical devices. Now since 13 years, Axeme has been recruiting talented professionals for biotech, medtech and IVD companies. Its expertise is based on listening capabilities, reactivity, and a deep understanding of the healthcare field and its associated jobs.
Mr. Mathieu CHARLEUX
International business development and strategy
Mathieu brings over 15 years of experience in international business development of medical device companies, from start-ups to well established organizations. Specialized in medical devices, his goal is to always share his experience allowing companies to rethink their business models and international business expansion strategies.
Mrs. Emmanuelle DURA-BADEZ
Clinical evaluation, Literature review, Clinical studies, Regulatory filing
Doctor in genomics and health, holding a BSc. in Clinical Studies Investigation, Emmanuelle worked in a university hospital setting on fundamental research and clinical studies project management. Working today to assist medical device manufacturers on clinical evaluation needs, specifically since the revised Meddev 2.7/1 on clinical evaluation reports.
Mr Alain VALORGE
ISO13485:2016, New MDR 2017/745, CE, 510(k), STED, AMDEC, audits…
Bringing over 15 years experience at various stages of the life of a medical device, Alain helps companies build and grow their internal means to overcome quality and regulatory challenges.