Biomaterial Regulation

Medical Devices Regulatory Concepts

Speakers: Javier Varela and Dr. Gonzalo Arévalo

Audience:  For scientists and other persons interested in learning (more) about iPSC

Topics: 

    1. Regulatory Framework 
    2. Documentation Requirements for a Product as a Stand-Alone Medical Device or as Part of a Combined ATMP
    3. Biocompatibility Requirements Applicable to Biomaterials when Developed as Medical Devices