CSV & CSA for MedTech Software Systems
Risk-based CSV/CSA for regulated MedTech software systems with clear intended use, defensible scope, and evidence that holds up in audits.
Talk to me: info@techkrates.com • +41 783 20 66 33
What I help you achieve
- Clear validation scope aligned to intended use and criticality
- Risk-based evidence without document-heavy overhead
- Traceable requirements-to-test coverage for key workflows
- CSA-aligned strategy for frequent changes and dependencies
Typical deliverables
- Gap assessment and criticality mapping
- Validation plan and test strategy (CSV or CSA, as appropriate)
- Risk-based test scripts and evidence capture guidance
- Data integrity focus for regulated workflows
- Change impact assessment outline and re-validation triggers
Mini case
Problem: Legacy MedTech software with limited documentation and an upcoming QA review.
Approach: Intended-use workshop, criticality map, and targeted test evidence for high-risk workflows.
Result: Defined validation scope and a prioritized remediation plan accepted by QA.
Related insights
- CSA explained for MedTech: Fewer tests, not less safety
- CSV/CSA for connected HW/SW systems: Scope, traceability, test strategy