Mastering Medical Device Understanding Software as a Medical Device with Vivek Thakkar
Vivek Thakkar has over a dozen years of experience in regulatory affairs for Class II and III medical devices, while at Roche, JUUL, Cardinal Health, and Abbott Vascular. He is also a frequent speaker on software, artificial intelligence, and machine learning. Vivek is now focused on start-ups and consults with medical device companies to identify and refine their regulatory strategies in the software as a medical device space.
In this episodeVivek shares the definition of software as a medical device, the regulatory requirements during product development, how hardware and software programs are similar and different, working with teams that do not have a medical device background, how changes are made to software products, AI and machine learning and what is being done today vs. what will be coming, and the challenges specific to software products that the industry and regulatory bodies are attempting to overcome.
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