This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some key points like safety and performance aspects for medical device software, Clinical Validation for Medical Device Software and Regulatory Referential for Medical Device Software - Europe and more are discussed.

Christophe Amiel, MSc, Senior Director, Medical Devices & Digital Life Sciences

Christophe Amiel is heading the design and implementation of regulatory strategy as Senior Director within Voisin Consulting Life Sciences for medical devices (including in vitro diagnostics), digital life sciences, as well as combination products (drug-device association) including activities related to Clinical Trials Application and vigilance.

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