Device Incidents Module
About the module
Intake device information in structured MIR forms or unstructured text from affiliates, partners/contractors – or even directly from consumers
Manage device case processing in HALOPV, including site/manufacturers evaluations, ÍMDRF coding etc.
Integrates to the Submissions module, to auto-generate a number of formats including MIR, eMDR, FDA combination products etc. This also allows for tracking the number of actual MIR reports sent out based on requirements (auto-scheduling available if Requirements Intelligence module is enabled).
Reconcile device reports from local, clinical etc. sources with HALOPV
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud
*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.
Want to know more, get a demo or take it for a test drive?
We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. Just email firstname.lastname@example.org.
We look forward to working with you.