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Medical Device Program

Class Definition of your Medical Device.

Establish a Quality Management System.

Risk Management Plan for CE Marking and/or FDA clearance.

Clinical Evaluation. How to design, when to apply and more.

Build your Strategic Roadmap for evidence demonstration and Registration Dossier filing.

Access to Market to identify and estimate the target populations, as well as the price potential.

CE mark vs FDA requirements, setting one foot on each side of the Atlantic NGHD’s DNA.

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 IVDR 2017/746/EU

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

Dedicated team

Post thumbnail Christophe Amiel, M.Sc.

Christophe Amiel, M.Sc.

Senior Director, Medical Devices & Digital Life Sciences

Post thumbnail Michael Husband

Michael Husband

Director, Medical Devices and Combination Products

Anne-Charlotte Jarrige, Ph.D. thumbnail

Anne-Charlotte Jarrige, Ph.D.

Senior Regulatory Scientist, Clinical Trials and Regulatory

Philip Brame thumbnail

Philip Brame

Director, Medical Devices​


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