The variety of profiles within our ranks is a guarantee of complementarity between all CEISO activities. Coming from Notified Bodies, healthcare industries, hospitals, and academia, our project managers have all been working in the biomedical regulations field for many years.
Gérard Luzergues, President-Founder of CEISO, has been working in the Medical Device regulation field for over thirty years, starting with the French homologation in the anesthesia-reanimation sub-commission.
In 1994, he was part of the team appointed by the Ministry of Health and the Ministry of Industry to establish the French Notified Body GMED. Within the Notified Body, liaising with the general delegate, he was responsible for external relations to explain the implementation of European Directives to companies, the academic world, and Chambers of Commerce.
Back in 1999, Gérard Luzergues founded and started heading the CEISO consulting firm, specialized in the field of Medical Devices, whose mission is to support companies in their innovative project – from inception to regulatory market approval.
In 2010, he created CEISO’s clinical department, MediaClin, dedicated to Medical Devices within clinical research, making CEISO one of the few regulatory consulting firms that integrates the entire value chain to obtain CE certification.
Gérard Luzergues has also been particularly involved both in the biomedical industry and in the territories where CEISO has a foothold.
He notably participated in the AFNOR working group for the development of the harmonized standard EN ISO 14971: Management of Medical Device Risks.
Gérard Luzergues sits on the Scientific Project Council (CSP) and the Board of Directors of the South of France competitiveness cluster dedicated to Healthtech EUROBIOMED, covering the Occitanie region and the Provence Alpes Côte d’Azur region since its creation in 2009.
A strong believer in exchanging among peers, Gérard Luzergues is also a member of BIOMED Alliance and Leader Occitanie where he shares his experience with entrepreneurs in the Occitanie region.
For more than 15 years, Gérard Luzergues has also been involved in the training of biomedical engineers, through interventions on European regulations related to Medical Devices for Polytech Marseille.
Finally, Gérard Luzergues is a member of the Evaluation Audit Committee (CAE) as an auditor, tasked with evaluating sectoral standardization offices for accreditation by the Ministry of Industry.
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