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

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