Audit-ready delivery for regulated software, devices, and healthcare AI.
Senior, hands-on systems and software leadership to reduce delivery risk, strengthen traceability, and build release evidence that stands up to scrutiny across UK/EU regulated environments.
PhD (Biomedical Engineering) · 25+ years engineering leadership · Architecture authority · Evidence-driven delivery
Evidence chain thinking, made practical: requirements → risk → design → verification → release.
The Evidence Chain
From intent to release: a coherent, defensible path for regulated systems.
Architecture & Boundaries
Decomposition, interfaces, and decision rationale captured early to reduce integration risk.
Traceability & Risk
ISO 14971-aligned controls linked to requirements and verification as the product evolves.
Evidence-Driven Delivery
Pipelines and quality gates designed to generate reviewable evidence for release readiness.
Where this helps most
When delivery risk is rising
Architecture drift, unclear requirements, integration surprises, or release confidence dropping.
Outcome: fewer unknowns, clearer decisions, better execution rhythm.
When audit readiness is uncertain
Traceability gaps, weak linkage between risk controls and verification evidence, or inconsistent release artefacts.
Outcome: a coherent evidence chain and a defensible release narrative.
Credibility signals (optional)
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Next step
30-minute discovery call
Context → risk hotspots → evidence gaps → practical next steps.
Prefer to start with a document?
Request the capability statement from the contact page and I’ll share a succinct overview of engagement options.
(Link your PDF on the Contact page when ready.)