Aligned Elements users can kick start their risk identification process by downloading and importing our ISO 14971:2012 Annex C Extension, assessing them, and start generating risks and mitigation.
The ISO 14971:2012 Annex C Extension contains:
- RVT file for an ISO 14971 Annex C Question (becoming the ISO 24791 Annex A in the 2019 edition) and a corresponding DOCX Reporting style template
- 42 importable questions built on Annex C in ISO 14971 to assess and integrate into your Risk Assessment
This Extension facilitates the assessment of the questions, the creation of both an automated assessment report of the Annex C questions as well as a starting point for generating new risks and mitigation.
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 ISO 14971 Annex C extension with your existing template set.
