Case Study: Philips achieves streamlined complaint handling and regulatory reporting with AssurX

Medical Device Leader Streamlines Complaint Handling and Regulatory Reporting to Successfully Navigate Organizational Growth

Philips’ Spectranetics business unit faced a manual, paper-based complaint handling and regulatory reporting process that created delays, limited visibility, and made global compliance difficult across multiple regulatory regimes. As complaint volumes grew, the team needed a more flexible way to manage workflows and reporting, so they turned to AssurX Complaint Handling.

AssurX implemented a configured solution with centralized complaint data, automated decision trees for reportability, and direct FDA submission. The result was better reporting quality, stronger control, and improved efficiency; Philips also reduced license needs from 160 to 80 concurrent users and was able to file U.S. FDA reports on time, even as late as day 29.

Philips

Jason Hearn

Senior Complaints Manager