This package contains predefined Potential Hazards, Causes, and Harms derived from the IMDRF Terminologies for Categorized Adverse Event Reporting.
The lists are applicable to Aligned Elements projects using Risk Assessments using the Preliminary Hazard Analysis method.
It is possible to import the IMDRF items directly into Aligned Elements by using four import packages which you can download here.
The extension consists of lists containing a Design Control type called “IMDRF Item”, which have the attributes “Code” and “Definition”.
When importing them, you will need to map the types to types that exist in your configuration.
Note that the lists contain a large number of items that may not all be applicable to your particular device.
A pre-assessment step of the list content is therefore recommended before applying them to production projects.
The following mappings should be done.
- “Annex A, Medical Device Problems” (469 items) should be mapped to a type that represents “Potential Hazards” in your configuration.
- “Annex D, Investigation Conclusions” (35 items) should be mapped to a type that represents “Causes” in your configuration.
- “Annex E, Health Effects - Clinical Signs and Symptoms or Conditions” (797 items) should be mapped to a type that represents “Harms” in your configuration.
- “Annex F, Health Effects - Health Impacts” (64 items) should be mapped to a type that represents “Harms” in your configuration.
This Extension accelerates the risk identification process and leverages the established risk terminology defined by IMDRF.
Unzip the downloaded file. Import the xml files into Aligned Elements.
It is advisable to test the import in a temporary project before applying the lists in a production project.
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.
