Change Control SaMD, Validating Azure Dev Ops for using it as document control tool

[AtulD]

hi
1) SaMD or Medical device software gets frequently updated. It becomes hard to keep the DHF index updated with every release since it is a manual process . Are there any tools or better ways to do this?

2) Azure Dev Ops as a tool can also store documents. , how should we go about validating that feature of dev ops or in general validating azure dev ops?

3) Can anyone please suggest a good training for Design Controls for SaMD type of devices/Mobile apps/Informatics.Typically lot of regulatory classification training are available but not seen any which specifically talk about design controls aspects of these devices

Thanks!!

 

[yodon]

I was hoping there would be other responses, but since nothing yet, I'll wade in.

For 1), it's hard to reply since we don't know the difficulties you're having. There are myriad tools. If you're trying to churn out a new release of a Medical Device (SaMD) daily, yeah, you're going to tie yourself up in knots!

Side note: there's no requirement for a DHF index.

For 2), I would not try to validate Azure Dev Ops. There may be some activities you want to take on to ensure that whatever you're doing with it will support regulatory requirements (record retention, access permissions, change management) but this is a heavily used commercial product and public use has done more testing that you could ever do. You may want to look at the FDA (draft) guidance on computer software assurance. That might give you some ideas on approaches.

For 3), not sure about training but maybe look at IEC 62304 and IEC 82304. That might provide a 'rosetta stone' for translation.

 

[AtulD]

Thank you Yodon, Appreciate your response on this one.