Who I work with
Typical client profiles and engagement models designed for regulated environments where credibility, clarity, and evidence matter.
Experience across recognised engineering environments
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Typical client profiles
MedTech startups (pre-market, scale-up)
When you need a regulation-first engineering path that reduces rework and builds defensible evidence early.
Established medical device manufacturers
When delivery risk, architecture drift, or evidence gaps require senior intervention and pragmatic governance.
Pharma & diagnostics R&D teams
When cross-disciplinary workflows need clearer requirements, verification strategy, and controlled delivery rhythms.
Healthcare AI innovators
When AI/ML integration requires guardrails, validation expectations, and coherent risk-control thinking.
Engagement models
Fractional Head / Principal Engineer
Ongoing leadership: architecture authority, governance, and risk-conscious delivery support.
Programme or Systems Lead
Define boundaries, interfaces, requirements quality, and evidence-led delivery structure.
Risk & compliance remediation
Close traceability gaps, align artefacts to expectations, and reduce audit anxiety.
V&V strategy and execution support
Verification model, traceability linkage, and evidence packaging for confident releases.
Architecture and design authority
Decisions and rationale captured; integration risks surfaced early; teams aligned.
How and when to engage
Engage Transvolve when you need senior leadership to reduce risk quickly: audit readiness, architecture uncertainty, traceability gaps, AI/ML integration risk, or evidence-poor pipelines.
A 30-minute discovery call typically confirms scope, identifies risk hotspots, and defines a pragmatic plan.