In this episode of the Di Renzo Regulatory Affairs Podcast, we explore a question at the heart of digital health compliance: When does your software become a medical device? Drawing from our latest article “How to understand if the software is a medical device?” we dissect the critical concept of intended medical purpose—diagnosis, prevention, monitoring, or treatment—and how it transforms standalone software into a regulated medical device.If you're developing health-focused software—whether it's tracking patient metrics, analyzing data, or offering diagnostic support—this episode guides you through the essential criteria: does your tool carry an intended medical use? If yes, you need to treat it as a medical device: from EU MDR classification to validation and regulatory obligations.By the end, you'll confidently answer: “Is our software a medical device?”, and know the steps to bring it to market.

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