Software to Manage IEC 62304 Traceability Requirement

[yyoossssii]

Hello,

We have around 20 medical devices under IEC62304 and the management of the Traceability is very complex (we are working with Excel spreadsheet).

I'm looking for a SW that is able to link System and SW and requirements / Verification & Validation / Risk Management.

Thanks

 

[yodon]

DOORS is, I guess, somewhat of an industry standard. It's expensive & requires a good deal of internal support. We used Polarion at one point because the tagged items are managed in the deliverables (documents) but licensing made it too difficult for us to use.

We ended up having someone here write a tool to help us manage the traces.

 

[ECHO]

JAMA has been my go to. Visure is also another solution.

 

[Enternationalist]

If you're big enough, an in-house solution is not a bad idea. You need flexibility.