A risk-based statistical sampling plan for medical devices adjusts sample sizes and testing criteria according to the potential impact of failures, guided by historical data and risk assessments. This method efficiently ensures product safety by matching testing intensity to the severity of possible risks --- Send in a voice message: https://podcasters.spotify.com/pod/show/dinalakayan/message
In this podcast, regulatory experts discuss the extended deadlines under the Medical Device Regulation (MDR), focusing on the transitional periods for various classes of medical devices. --- Send in a voice message: https://podcasters.spotify.com/pod/show/dinalakayan/message
In this episode of MDR Chats, we delve into the intersection of artificial intelligence and medical device regulation under the new EU Artificial Intelligence Act. This episode is created by chatMDR.eu . The voices in this podcast are AI-generated. --- Send in a voice message: https://podcasters.spotify.com/pod/show/dinalakayan/message
Better understanding of the PRRC's role, responsibilities, and operational considerations for manufacturers and other economic operators. The voices in this podcast are AI-generated. --- Send in a voice message: https://podcasters.spotify.com/pod/show/dinalakayan/message
MDRChats is your go-to podcast for the latest insights and updates on Medical Device Regulation, tailored for those with busy schedules. Our episodes are designed to enhance your understanding of MDR, keeping you informed and ahead in a rapidly evolving field. Subscribe to MDR Chats and effortlessly learn more about Medical Device Regulation. --- Send in a voice message: https://podcasters.spotify.com/pod/show/dinalakayan/message