Demystifying the FDA Regulatory Path and Profession for Medical Devices and Software

A panel of regulatory affairs professionals will provide an overview of common medical device regulatory pathways for products including standard hardware/software, Software as a Medical Device (SaMD) and AI applications. They will also address how and when to work with expert professionals. Designed for faculty, postdocs, graduate students and others translating research into commercial healthcare products. Presented by Discovery to Product (D2P), Forward BIOLABS and The Isthmus Project.