Help needed for Compliance Road-Map - Startup making their first device (IVD)

[dukakis]

There is a startup making their first device (IVD). Aiming at Class A arguing that it will be stated that the results should always be checked for consistency with symptoms etc. In worst case, could be Class B. Mostly embedded s/w with GUI on top. Most of the code is ready (all of the core parts) and the prototypes are being tested for functionality. There is no documentation, except for the functional test procedure for the device. No s/w tests whatsoever, arguing that if h/w module passes tests, s/w driving it passes as well.

What would be the steps to back-document and bring this device into compliance status?

Thank you!

 

[yodon]

I guess the simple answer would be for you do do a gap analysis (ISO 13485) and let that drive the documentation.

Since you mentioned software, you'll probably want to take a look at IEC 62304, the software life cycle standard.