The widespread adoption of mobile and wireless technologies, including smartphones and tablets, has given rise to the growing field of mobile health (m-Health) which is poised to revolutionize sectors of healthcare. The rapid pace of growth in m-Health presents developers with key challenges in designing and implementing new mobile solutions.
The purpose of this white paper is to help developers navigate the development and regulation maze of m-health products. In this paper, we discuss the definition and uses, international regulatory environment for m-Health as medical devices, and the key development constraints and product evaluation activities of m-health technologies.
Christophe Amiel, Senior Director Medical Devices & Digital Life Science
Christophe 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.