Understanding Software as a Medical Device with Vivek Thakkar

Mastering Medical Device

Patrick Kothe에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Patrick Kothe 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.

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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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Vivek Thakkar LinkedIn

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