ELearning and Manual for Software as a Medical Device
A Fortune 500 medical device company hired Brilliance Mining to capture essential expertise from multiple specialists and build an accurate, easy-to-use training system for a new software-as-a-medical-device. The result: clear eLearning modules and a comprehensive manual technicians could rely on — supporting the FDA approval process and ensuring safe, confident use.
The Challenge
A Fortune 500 medical device company developed new software for one of its diagnostic devices — software that required FDA approval and precise technician training before it could be used in the field.
The expertise needed to create this training system lived in the brains of several experienced staff members spread across different departments. Many of them had a high workload.
Each team had part of the knowledge, but no complete, unified training existed — in an FDA-regulated environment where inconsistent training can cause delays or safety concerns.
Without this:
- Technicians couldn’t participate in required usability testing for FDA approval of the software
- No single “source of truth” existed to ensure safe, consistent training
The company needed one clear, accurate training system — fast.
The Intervention
Brilliance Mining gathered essential knowledge from the right experts and shaped it into training technicians could immediately understand and use. The work entailed:
- Extracted software features, safety considerations, and decision points
- Standardized terminology and clarified details
- Mapped the complete workflow technicians would follow
- Developed accurate eLearning modules and a comprehensive manual
Everything was built to be clear, consistent, and simple for technicians.
The Result
The company now had:
- Accurate eLearning modules and a comprehensive, FDA-aligned manual that consolidated expert knowledge
- A reliable foundation for technician training, usability testing, and safe device operation
Technicians could train with confidence, and the company had the documentation needed for a smooth regulatory approval process.
The Impact
Clear, consistent training for regulated software as a medical device
- Reliable readiness for FDA usability testing
- Safe, confident technician use of the new software
A clear knowledge base for future updates and training