Anastacia Bilek, Ph.D. will share her experience in the regulation of m-Health products as a guide for product developers. She will discuss the definition and uses of m-Health, the regulatory environment for m-Health, and the key development and evaluation activities of m-health technologies.

Anastacia M. Bilek, Ph.D. Associate Director, Medical Devices & Combination Products

Anastacia M. Bilek, Associate Director Medical Devices & Combination Products 

She is responsible for multiple client projects involving the implementation of US regulatory strategies and submissions for the development and marketing of medical devices and combination products.

Christophe_Amiel

Christophe Amiel, Senior Director Medical Devices & Combination Products 

Christophe is leading design & implementation of regulatory strategies for medical devices (incl. IVD), combination (drug, biologic) & borderline products. His areas of expertise encompass clinical development, EU/US market approval & MD vigilance.

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