A robust Excel compliance spreadsheet should be divided into multiple tabs or columns representing the core processes outlined in the standard. Every row in your sheet should represent a specific clause or requirement. Essential Data Columns for Your XLS Sheet
26, 12.2, "Record retention", Documentation, "Define retention periods and storage for lifecycle records", "Records retention schedule", "Records retained per regulatory requirements", Not Started, QA, , , Low, Iec 62304 Checklist Xls
The standard applies to both standalone medical software (SaMD) and software that is embedded or an integral part of a final medical device. It is referenced by the FDA, cited in EU MDR technical documentation requirements, and recognized by regulatory authorities in Canada, Japan, Australia, and most other major markets. A robust Excel compliance spreadsheet should be divided
This section ensures you maintain total control over your source code and development environment. It is referenced by the FDA, cited in