IEC 62304 Checklist for Software 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.

We give you a fast and trackable way to do just that!

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.

Download it here.