VCLS Webinar Series

Development and registration of m-health technologies for the EU market

Presenters: Christophe Amiel, Senior Director, Medical Devices and e-health & Marielle Fournier, Senior Director, Medical devices and Combination products

Date:          May 31, 2016

Duration:    45 Minutes

e-health technologies are already today starting to revolutionize the therapeutic processes and patients management paradigm. Unfortunately, e-health developers are very often uncomfortable with the regulatory maze they have to navigate into (or are simply unaware of it) until their e-health products could be placed on the European market.

Key learning objectives:

  • European regulatory framework applicable to m-health technologies

  • m-health products development and evaluation

  • Critical regulatory challenges for the EU market

Christophe Amiel, Senior Director at VCLS, will share his experience on these innovative m-health technologies and the associated development hurdles. He will illustrate critical matters related to the regulatory environment relevant to e-health products and how to best overcome these challenges for derisking market launch in Europe.

About the presenters:

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

About VCLS:

VCLS supports life science companies and engages in communication with regulators and payers to develop, register and launch innovative health products in global markets.

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