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Medical Device Program

Target Product Profile: Definition of the key features of your product to build your industrial development roadmap.

From Academic Research to Patients: Advancing methods to ensure a smooth transition from academic work to the first industrial and regulatory data.

Regulatory Landscape: Build the interaction plan and strategy of communication with EMA & FDA.

Nonclinical Development: Choose the right model for your evidence based strategy.

Clinical Plan: The backbone of your entire development plan.

CMC Accelerated Development: Help in achieving a scale up of your production method.

From EU to US: Suit your innovative therapy to international regulatory framework.

Access to Market: Identify the target population & price potentia

Digital Option

Digital Medical Device conception (62304 implementation)

Establishing a software under the Medical Device status is a challenge, different standards apply, development under the “agile” form is possible under certain conditions.

IVD (In Vitro Diagnostic) Option

Implementation IVD 98/79/EC

The development of an IVD follows a specific regulation which evolves with the new adjustment.

Dedicated team

Post thumbnail Marielle Fournier, Pharm.D.

Marielle Fournier, Pharm.D.

Senior Director, Drugs, Devices & Combination Products

Post thumbnail Christophe Amiel, M.Sc.

Christophe Amiel, M.Sc.

Senior Director, Medical Devices & Digital Life Sciences

Post thumbnail Michaël Auffret, M.Sc.

Michaël Auffret, M.Sc.

Director, Medical Devices & Digital Life Sciences


bioadhesive ophtalmics
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