Build a Quality Metrics Program for a Medical-Device Software Team
Overview
What this challenge is about.
Design 12-15 quality metrics, build a Metabase dashboard, run a 4-week pilot, and map to IEC 62304. Get a verifiable certificate.
The scenario
The medical-device manufacturer (FDA-inspected every 2 years, ISO 13485 certified) plans an FDA 510(k) submission for a new diagnostic indication next year — the QA director needs a measurable quality baseline before the audit.
The Brief
What you'll do, and what you'll demonstrate.
Design and pilot a quality-metrics program for a 38-person medical-device software team with IEC 62304 traceability.
Earning criteria — what you'll demonstrate
- Design a quality-metrics catalog aligned with IEC 62304
- Distinguish process metrics from product metrics with care
- Build a dashboard that auditors and engineers both trust
- Pilot a metrics program without it becoming a leaderboard
Program Fit
Where this fits in your program.
Sharpens the same skills your degree expects you to demonstrate.
Software Quality and Process Improvement
Master · Software Engineering
Strong alignment
This challenge maps to Software Quality and Process Improvement at the Master level. It sharpens the same practical skills your coursework expects — but in a real industry context with actual constraints and deliverables.
Skills
Skills you'll demonstrate.
Each one shows up on your verified credential.
- Quality Metrics
Apply quality metrics to solve real industry problems and demonstrate production-level capability.
- Iec 62304
Apply iec 62304 to solve real industry problems and demonstrate production-level capability.
- Process Improvement
Apply process improvement to solve real industry problems and demonstrate production-level capability.
- Measurement
Apply measurement to solve real industry problems and demonstrate production-level capability.
- Traceability
Apply traceability to solve real industry problems and demonstrate production-level capability.
- Stakeholder Communication
Apply stakeholder communication to solve real industry problems and demonstrate production-level capability.
Careers
Career paths this challenge builds toward
Completing this challenge demonstrates skills that transfer directly to these roles: