Regulatory Pathways for Medical Software: A Discussion with Holland & Knight
Healthcare & Life Sciences attorneys Michael Werner and Sara Klock were featured in a Q&A with the Mayo Clinic Innovation Exchange on the U.S. Food and Drug Administration's (FDA) approach to regulating medical software. They discussed what entrepreneurs and innovators should keep in mind before going to market as well what questions teams should ask to determine if their product qualifies as a medical device. They also shared the breakthrough innovations they're most excited to see.
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