Build the regulated software quality capability your team needs
Structured training and expert SME hours for medical device companies building SaMD — aligned to IEC 62304, ISO 14971, FDA QMSR, and beyond.
Why MSQI?
Structured curriculum
Sequenced modules covering IEC 62304, ISO 14971, FDA QMSR, cybersecurity, and AI/ML — built for regulated software teams, not generic developers.
Expert SME hours
Monthly allocation of dedicated subject-matter expert time. Non-rolling (use-it-or-lose-it) to drive consistent engagement and real capability growth.
Capability Dashboard
Visible team trajectory for managers — track module progress, SME session outcomes, and hire-readiness signals across your entire team.
How it works
- 1
Onboarding diagnostic
We assess your team's current capability baseline and create a personalised learning path.
- 2
Module learning
Learners progress through structured async modules with embedded assessments at their own pace.
- 3
SME expert sessions
Monthly SME sessions reinforce learning, answer domain questions, and build real-world confidence.
See MSQI in action
See MSQI in action — video coming soon
Built for QA/Regulatory and Engineering teams in medical device companies
Whether you're preparing for an FDA submission, CE marking, or scaling your engineering team's IEC 62304 knowledge — MSQI provides the structure your team needs.
Ready to build team self-sufficiency?
Join medical device companies who are systematically building regulated software quality capability.
Book a demo