Defines processes for capturing, investigating, and resolving defects or complaints. Safety Classification Impact
The IEC 62304 Checklist is a structural tool used to ensure medical device software life cycle processes meet international standards for safety and compliance. It maps specific regulatory requirements to the documentation and activities required for different software safety classes. Iec 62304 Checklist Xls
Create a covering all lifecycle activities. Create a covering all lifecycle activities
Indicates if the task is required for Class A, B, or C software. Defines processes for capturing
A robust Excel checklist should be organized by the five main process groups defined in the standard (Clauses 5 through 9). 1. Software Development Process (Clause 5)
for the XLS (e.g., Clause #, Requirement, Evidence, Status)? Are you integrating this with a Risk Management process (ISO 14971)? I can provide a detailed breakdown of the sections you should include in your spreadsheet.