IEC 62304 Checklist for audits

If you develop software for a medical device then you have hopefully aligned your processes with IEC 62304 - Medical Device Software 

In an auditing situation, you might be required to demonstrate how you comply to this standard.

Our IEC 62304 Checklist is integrated in Aligned Elements and lets you perform the assessment inside AE, taking advantage of inconsistency rules, tracing to existing project documents as objective evidence and simple export to word once completed.

The checklist includes 93 prepared audit questions based on the requirements in IEC 62304.

This is a simple and efficient way to demonstrate your company and software's compliance with the standard.

How to use the Extension:

Download and unzip the extension file.

  • Add the IEC 62304 Checklist.rvt and IEC 62304 Checklist.docx templates to your template set.
  • Import the IEC 62304 Checklist Items.xml file. Make sure that the import setting "Recreate Chapters" is active.
  • Use "Update Multiple Items" to set your device's Software Safety Classification in all checklist items.
  • Assess each requirement for its applicability based on the Software Safety Classification for the device and for the requirement.
  • If the requirement is not applicable, qualify your answer.
  • If the requirement is applicable, explain and demonstrate how you have fulfilled the requirement and refer to objective evidence, optionally by tracing to existing File Objects.
  • When completed, create a Word Document for the now filled out Checklist.