A great way of conducting a structured risk identification is to start off with a known list of potential hazards. ISO 14971:2012 Annex E (ISO 14971:2019 Annex E) provides such a list that can be downloaded and imported below.
The ISO 14971 Hazard Examples contains:
- 74 importable potential Hazards built on Annex E in ISO 14971:2012 (ISO 14971:2019 Annex E) to assess and integrate into your Risk Assessment
The imported items correspond to the Hazard Design Control in the Aligned Elements FDA Templates.
Unzip the downloaded file. Import the xml file containing the questions into Aligned Elements and map them to a Potential Hazard / Hazard type.
Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for support and information.
