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Development and Registration of m-Health Technologies for the EU Market
Published on: May 31st, 2016
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.