The Technical Report, IEC TR 80002-1 "Medical device software - Part 1 Guidance on the application of ISO 14971 to medical device software", takes a software angle on ISO 14971, just as the title suggests.
Annex B of the report elaborates on possible software hazards and factors to consider in order to properly assess whether and how they are applicable to a particular device.
To assist the risk identification of software hazards, use this extension, inspired by the Annex B of IEC/TR 80002-1.
It includes:
- RVT file for a Software Hazard aspect and a corresponding DOCX Reporting style template
- 70+ importable potential Software Hazards to assess and integrate into your Risk Assessment
You may of course expand this hazard list with hazards that are particular to your device and the conditions under which it needs to operate.
Unzip the downloaded file. Place the rvt and docx files in your template folders. Import the xml file containing the questions into Aligned Elements.
Contact This email address is being protected from spambots. You need JavaScript enabled to view it. to configure your templates for the best integration of the extension into your existing template set.
