This document provides the structural framework for an IEC 62304 compliance checklist. By transferring this content into a spreadsheet format, organizations can create a dynamic tool for tracking compliance, managing traceability, and preparing for regulatory audits (FDA, MDR, MHLW). Remember that the level of rigor applied to the checklist must match the Safety Classification of the software (Class A, B, or C).
IEC 62304 is an international standard for medical device software, developed by the International Electrotechnical Commission (IEC). The standard outlines the lifecycle requirements for the development, deployment, and maintenance of medical device software. Its primary objective is to ensure that software used in medical devices is safe, reliable, and performs as intended. Iec 62304 Checklist Xls
I have organized this into within a single Excel file. This document provides the structural framework for an