Conseil Strat├ęgie M├ędicale

More than consultants, a dynamic!


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

Our customers are companies developing or manufacturing medical devices and the pharmaceutical industries.

Our consultants assist our clients in addressing technical, 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 standards, at a lower cost.



Medical devices regulation

MDCG 2023-1 - Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Medical devices regulation

Extension of transitional period of Medical Device Regulation (MDR 2017/745)

Medical devices regulation

MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR

Medical devices regulation

MDCG 2021-24 Guidance on classification of medical devices - October 2021