TechkratesCSV to CSA for a connected device add-on
A connected hardware add-on with several software services, cloud components and data flows, US-bound in an FDA context, with frequent changes and many dependencies.
Problem
The system touched hardware, embedded control, cloud data flows and several integrations. Every change created a large dependency surface and another validation cycle.
Approach
- Risk-based CSV boundaries by criticality and intended use
- Traceability across hardware, software, integrations and data integrity points
- Test scripts and evidence capture for the key workflows
- Dependency mapping and structured change impact assessments
- CSV cycles for major changes, with a gradual move to CSA
Result
Audit-ready evidence across the integrated components, clearer change control and faster iteration cycles.
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