Device Incidents Module

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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.

Further details

From Case Intake to manufacturer assessment, HALOPV takes the hard work out of managing the Device reporting process. It is part of the set of Case processing modules

Want to know more, get a demo or take it for a test drive?

We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail. 

Write to sales@insife.com - we are looking forward to helping your organization!