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CSV → CSA for a Connected Device Add-On (US-bound)

An anonymized CSV/CSA project for a connected hardware add-on with multiple software services, cloud components, and data flows. The product was US-bound in an FDA context, with frequent changes and many dependencies driving repeated validation cycles.

Problem

A connected device add-on plus several software services needed validation for US-market release. The system touched hardware, embedded control, cloud data flows, and multiple integrations, creating a high dependency surface and rapid change cadence.

Approach

• Risk-based CSV scope defined by criticality and intended use
• Traceability across HW/SW, integrations, and data integrity points
• Test scripts and evidence capture for key workflows
• Dependency mapping and structured change impact assessments
• Repeated CSV cycles for major changes, with gradual CSA adoption to maintain agility

Result

Audit-ready evidence across integrated components, clearer change control, and faster iteration cycles for a complex connected system.