The IEC 62304 standard includes requirements for managing the life cycle of medical device software, from design and development to manufacturing, distribution, and post-market surveillance. This illustrated guide was written by Wasif Ali Syed, This guide will: What is medical…
Handling Out of Specification (OOS) results effectively is a challenge. Despite rigorous processes and controls, OOS results can and do occur. Understanding what they are, why they matter, and how to manage them is essential for maintaining compliance and ensuring…
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