Eloïse Le Rolland

Senior consultant in clinical strategy and clinical evaluation of medical devices, I support manufacturers, medtech start-ups, CROs, and clinical departments in structuring, securing, and optimizing their high-stakes regulatory and operational projects.

With a background in clinical research, combining field experience, project management, strategy, and business development, I address both operational issues and positioning, feasibility, and compliance challenges within the framework of the European MDR 2017/745 regulation and ISO 14155.

My approach is based on a pragmatic and holistic view of projects: aligning regulatory, scientific, human, and field needs to build realistic, effective clinical strategies adapted to the constraints of healthcare stakeholders.

I notably support:

the strategy and clinical evaluation of medical devices,

the implementation and management of clinical investigations,

interactions with stakeholders (manufacturers, investigators, CROs, laboratories, healthcare facilities),

the optimization of processes and regulatory documentation,

the development of synergies and collaborations in the medtech and clinical research ecosystem.

In parallel to my consulting activities, I also develop digital solutions dedicated to regulatory compliance and documentary structuring for medical devices, with a strong user and field orientation.

What characterizes me: a strong adaptability, a strategic vision combined with solid operational culture, and the desire to create concrete, useful, and applicable solutions for teams and projects.