Medical Device Software Risk Management - Challenges and Tips скачать в хорошем качестве

Medical Device Software Risk Management - Challenges and Tips

💥Software failures can lead to harm but they are not predictable! ➡️In this brief clip from a Let's Talk Risk! webinar, I discuss some of the challenges in software risk management using a case study of a recent recall. ✅Listen to the full recording of the webinar here ➡️https://naveenagarwalphd.substack.com... In this hour long webinar, we discuss the following topics: 👉Software failure example: Recall of a medical app to deliver insulin 👉Requirements for medical device software according to IEC 62304 👉Key concepts for medical device software risk management 👉2 key challenges and tips for medical device software risk management 👉Why probability of software failure is not the same as P1 👉Example of estimating probability of harm due to software failure 👉Overview of software FMEA as a risk analysis technique 👉Risk management file documentation structure 👉Audience Q&A ❓Interested in learning more about medical device quality, regulatory and risk management related topics? ✅Check out Let's Talk Risk! and join our community https://naveenagarwalphd.substack.com...