Iec 62304 - Checklist Xls

Here are the most accessible resources for acquiring or building your own IEC 62304 checklist in XLS format.

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. Iec 62304 Checklist Xls

Lock down the sheet prior to internal or notified body audits. Export the fully completed XLS sheet to PDF to be included within the Technical File for submission. Here are the most accessible resources for acquiring

List and identify all source code files, documentation, compilers, and third-party tools used in the build. Lock down the sheet prior to internal or

Start with your safety classification (A, B, or C), build or download a clause-by-clause checklist tailored to your class, and integrate the verification points into your daily development workflow. As regulatory experts emphasise, the content matters far more than the tool — but the right checklist makes everything easier, faster, and more reliable.

Assess how updates affect safety and existing device functionality. Module 7: Software Risk Management Process