Introduction: The Cost of Non-Compliance
However, reading the 100+ page standard is daunting. Implementing it is harder. This is where an becomes indispensable. An Excel spreadsheet might seem low-tech, but it is the perfect tool for gap analysis, traceability, and audit defense. Iec 62304 Checklist Xls
In the world of Medical Device Software (SaMD and SiMD), the difference between market approval and a costly recall often comes down to documentation. IEC 62304 is the benchmark standard for software lifecycle processes, harmonized by regulatory bodies like the FDA (US) and notified bodies under the MDR (Europe). Introduction: The Cost of Non-Compliance However