Case Study 02
cobas ePlex Demo Consumable — Launch
Research Associate, Process Validation & MSAT · Roche Diagnostics
Launch ReadinessIQ/OQ/PQCross-functionalIVD
The problem
Customers needed to experience ePlex diagnostic functionality without a live diagnostic product. The demo consumable had to feel like the real thing, work across global operations, and hold full regulatory traceability from day one.
The process
- 01
Translated IVD diagnostic functionality into a commercial-ready demo experience.
- 02
Authored and executed IQ/OQ/PQ validation protocols, keeping full traceability per 21 CFR Part 820 and ISO 13485.
- 03
Coordinated across global operations to confirm product readiness before launch.
The results
- Launch-ready across global operations.
- Full regulatory traceability maintained through validation — no gaps at audit.
- A demo experience customers can run that behaves like the real diagnostic.