Gen AI delivers $2.5M savings and regulatory compliance excellence
Optimized medical device reporting compliance using Generative AI-powered models that reduced manual effort in the complaint handling process.
Business Scenario
One of the largest medical technology companies in the world launched an initiative to streamline the complaint handling process using AI. Its medical management solutions unit handled high volumes of customer cases where rapid and accurate identification of complaints and medical device reporting is critical for patient safety and compliance. Manual workflows were used to determine whether a case qualified as a complaint, assess medical device reportability, and draft a Complaint Investigation Report (CIR) for remediation.
Sigmoid Solution
As part of the client’s enterprise-wide AI transformation, Sigmoid collaborated with business, compliance, and quality teams to identify key bottlenecks in the complaint handling process. We developed three AI models to enhance accuracy, speed, and readiness for compliance:
- Case Classification Model: Labels historical and incoming cases as complaint or non-complaint.
- GenAI-assisted medical device report determination Model: Surfaces reportable vs. non-reportable events and enhances reviewer decision-making.
- LLM-based Prompt Agent: Drafts Complaint Investigation Report sections and auto-populates reporting templates for reviewer sign-off.
Business Impact
yearly cost savings
reduced cycle time for clinical investigation reporting
increase in medical device reportability
