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Challenges in connecting risk management with design controls

The conceptual framework of linking risk management of medical devices with the design and development process is not very complex. Yet, there are many device-related recalls and safety incidents that often link back to the design. In this discussion, we are exploring the practical challenges in implementing an effective system of integrating activities in the risk management process with activities in the design process. We are also reviewing a recent recall to highlight some of the potential issues. This is only a starting point of our conversation on this topic. The intent here is to understand the practical challenges and have a conversation about best practices. 👉Subscribe to the Let's Talk Risk! newsletter https://naveenagarwalphd.substack.com/ 👉Connect on LinkedIn   / naveenagarwal