Automating Global Quality Compliance with AI-Powered Data Classification
Stellar helped a global medical device company eliminate a 100,000-case compliance backlog in a single afternoon using AI-powered data classification. Transforming a year-long manual process into an automated, scalable workflow.
A global medical device manufacturer with operations in over 160 countries and U.S. headquarters in Denver. The company produces life-saving equipment used daily in hospitals and clinics worldwide, including dialysis and cell therapy machines. To support its distributed device footprint, the organization operates a centralized technical support call center handling urgent troubleshooting requests from healthcare professionals around the globe.
Customer Challenges
The company was facing a serious backlog of unreported device incidents, over 100,000 case. A major compliance risk.
- Translation and Interpretation - Technicians in the field spoke various languages and relied on translation services to contact the U.S.-based call center.
- First-Line Support Gaps - Call center reps lacked deep technical expertise, creating a disconnect in problem resolution.
- Manual Workflows - Incident notes, call transcripts, and device logs were scattered across systems in various formats.
- Regulatory Pressure - The company was assembling a 6 – 8 person team to manually classify incidents and produce reports in government-mandated formats — a process expected to take a full year.
Stellar's Solution
Stellar delivered an AI-powered solution that unified and automated the entire incident reporting and analysis workflow.
- Multimodal Data Ingestion - Combined unstructured data (notes, transcripts, multilingual call audio) with structured machine data (IoT logs and telemetry).
- AI-Powered Classification Engine - Automatically reviewed and classified incidents in accordance with regulatory standards.
- Generative Summarization & Formatting - Converted cases into compliant government-ready formats in minutes.
- Root Cause Intelligence - Identified patterns and systemic failures — such as faulty components, poor manufacturing practices, and field training gaps.
- Scalable Multilingual Capability - Enabled accurate processing of incident data across dozens of languages and regions.
“Stellar has been a key AI partner for our company. Their Microsoft AI expertise has made a profound impact on our business operations and continually ensures we are deriving meaningful value with our AI investments.”
VP of Digital Transformation
OUTCOME AND BENEFITS
The AI solution cleared a year’s worth of compliance backlog — in a single afternoon. This radically accelerated regulatory reporting and opened the door to proactive quality improvements:
- 100,000+ Incidents Processed
- Cleared within hours instead of a projected year
- Full Compliance Achieved
- Government formats were automatically applied and verified for accuracy.
- People Redeployed Strategically
- Analysts once tied up in manual classification were reassigned to investigate root causes and improve operations.
- Improved Quality Control
- Pinpointed recurring issues tied to specific suppliers, factories, or training practices.