Free tools

IEC 62304 safety class calculator

Five questions, your likely software safety class, and the deliverables that class calls for. Based on IEC 62304:2006/AMD1:2015, clause 4.3.

Takes about two minutes. Any "Not sure" moves you toward Class C, because unclassified software is treated as Class C.

1Could a failure of your software contribute to a hazardous situation?

Count wrong, late, missing or unexpected output anywhere in the chain of events, for the patient, the operator or anyone nearby.

Get the PDF report

Your result, your answers and the full deliverables list on one branded page you can file with your rationale. Enter your name and work email and the report unlocks right here.

By entering a mobile number, you agree to receive text messages from Software Quality Guru about your request, new resources and The Quality Trace. Message frequency varies. Msg & data rates may apply. Reply STOP to opt out, HELP for help. A mobile number is optional and isn't required to get anything on this site.

I won't sell or share your details.

You're in

Thanks, you're in. Check your inbox.

Cookies on this site

Essential storage keeps the site working and remembers this choice. With your OK, I'd also use HubSpot to see which articles and tools are useful, and to show my booking calendar on the contact page. Nothing optional loads until you choose, and you can change your mind anytime from Cookie settings at the bottom of every page.

What each option does
Accept all
Essential storage, the HubSpot booking calendar, and HubSpot analytics cookies.
Essential only
Essential storage and the HubSpot booking calendar, which sets its own cookies when it loads on the contact page. No analytics.
Deny
Only what's needed to remember this choice. No analytics, and the booking calendar stays off until you click to load it.

Privacy policy: cookies and analytics