Conseil Stratégie Médicale

More than consultants, a dynamic!


Conseil Stratégie Médicale (CSDmed) is the leading Monegasque consultancy firm in the development of medical devices (MD) or drug-device combination products.


Our customers are companies developing or manufacturing medical devices, biotechnology companies using MDs, and the pharmaceutical industries.


Our consultants assist our clients in addressing technical challenges during development, quality assurance, and regulatory compliance challenges. Our team is made up of committed, human, and result-oriented experts. Our pragmatic approach allows our clients to comply with applicable regulations and standards, at a lower cost.


You are looking for an expert to manage an R&D subject, consult our page describing our expertise in project development and project management.

You are looking for an independent QA to build your Quality Management System (QMS), to manage your CAPA, to improve your processes, consult our page describing our Quality skills.

You are looking for a freelance professional to advise you and help you determine your regulatory strategy through MDR 2017/745, through FDA requirements, or through MDSAP (Medical Device Single Audit Program in Canada), CSDmed has the solution. Visit our page describing our regulatory expertise.

Contact us now to discuss the challenges we can address together.


Medical devices regulation

New issue of the MDCG Position Paper : MDCG 2022-11 revision 1

Medical devices regulation

Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics

Medical devices regulation

Implementing Regulation (EU) 2022/2346 and (EU) 2023/1194 of the arrangements in Annex XVI of MDR 2017/745 - risk management and transitional provisions

Medical devices regulation

The calendar according to amending regulation 2023/607