With over 17 years of experience in regulatory affairs and quality, Natacha has worked in various companies on a wide range of medical devices, from Class I to Class III implantable.
Her career is marked by efficient team management and active participation in Management/Steering Committees, where she significantly contributed to the company’s strategy and operational management.
Natacha has successfully contributed to the achievement of initial ISO 13485 and MDSAP certifications. As a project manager for the MDD/MDR transition, she played a key role in obtaining MDR CE marking for Class III medical devices.
Her expertise goes beyond Europe, having successfully registered medical devices internationally (Canada, Brazil, Australia, USA, EMEA countries). She excels in establishing effective regulatory strategies, ensuring compliance, and securing global market access for the company’s medical devices.
In addition, Natacha has built strong, trusted relationships with various notified bodies.
Her expertise ensures not only compliance but also the commercial success of your medical devices.

With over 20 years of experience in R&D, quality, and industrialization in various medical device companies, Mathieu stands out for his diverse and complementary skills.
He is proficient in new product design, including verification and validation, and has patented a medical device in collaboration with a renowned Key Opinion Leader (KOL).
Mathieu has also extensively managed operational quality, overseeing non-conformities, CAPA, batch release, validating product sterilization, and qualifying suppliers.
His expertise extends to industrialization, with proven skills in process validation, test methods, and computerized systems in production.
Additionally, he has strong capabilities in managing cross-functional projects, ensuring effective coordination and successful project delivery.