Case Study: Insulet Corporation achieves EU MIR complaint reporting compliance with CEPTES Software

To manage the complaints effectively and regulatory submissions

Insulet Corporation, a Massachusetts-based healthcare company, needed to update its complaint management and regulatory submission process to comply with the new EU Manufacturer Incident Report (MIR) requirements replacing MEDDEV. The company had been using CEPTES Software’s Complaint Management System and Complaints Solution on the TWD platform for years, but required an upgrade to support the mandatory EU MIR template and related incident reporting changes.

CEPTES Software upgraded the existing Salesforce-based solution and completed the necessary configuration and customization, including workflow, process builder, flows, and Apex triggers to automate the business process. The result was a successful EU MIR upgrade completed in December 2019, enabling Insulet Corporation to begin submitting EU MIR reports instead of MEDDEV.

Insulet Corporation