Regulated Excellence for Sophisticated MedTech Teams.
Traceability gaps, audit anxiety, and release confidence that depends on heroics—not evidence. I help senior engineering leaders rebuild the evidence chain so audits become routine and releases become defensible.
25+
Years Regulated Systems
PhD
Biomedical Engineering
100%
Evidence-Driven
You Should Talk to Me If…
These patterns signal that evidence chain work is overdue.
- ⚠️ Your DHF/traceability can't be assembled without heroics.
- ⚠️ Release readiness is a debate, not an evidence-backed state.
- ⚠️ Risk controls exist, but don't map cleanly to verification evidence.
- ⚠️ Audit prep feels like forensic reconstruction, not a routine export.
- ⚠️ Your pipeline ships builds, but doesn't generate reviewable evidence.
The Evidence Chain Framework
Three pillars that transform regulated delivery from uncertainty to confidence.
Architecture
Decomposition and interfaces designed to reduce integration risk early.
Traceability
ISO 14971-aligned controls linked to requirements as your product evolves.
Delivery
Quality gates designed to generate reviewable evidence for release readiness.
Where Uncertainty Becomes Clarity
Two critical areas where misalignment creates risk and wasted resources.
Delivery Risk
Architecture drift, unclear requirements, or release confidence dropping.
Audit Readiness
Traceability gaps or weak linkage between risk and verification evidence.
Why Regulated Leaders Choose Transvolve
Proven patterns across medical devices, pharma, healthcare platforms, and security-critical systems.
Reduce Time to Market
Architecture and governance clarity means faster delivery, fewer rework cycles, and earlier revenue recognition—without cutting corners on evidence.
Build Audit Confidence
Systems designed from day one with traceability, evidence capture, and quality gates that make regulatory conversations straightforward and low-risk.
Strengthen Team Alignment
Clear boundaries, documented decisions, and explicit responsibilities eliminate ambiguity across engineering, quality, and regulatory teams.
Start Here: Phase-1 Engagements
Defined scope. Fixed outcomes. Senior delivery.
Architecture & Risk Baseline
Time-boxed baseline · 2-3 weeks
Rapid assessment of system architecture, boundaries, and risk posture against IEC 62304 and ISO 14971.
You leave with: Architecture & risk gap summary, remediation priorities, audit-ready narrative.
Evidence Chain Recovery
Targeted remediation · 4-6 weeks
Restore traceability between requirements, risk controls, and verification where evidence has drifted.
You leave with: Coherent traceability model, defensible release position, verification roadmap.
Regulated DevSecOps Foundation
Foundation engagement · 4-6 weeks
Design a compliance-aware CI/CD framework that generates audit-useful evidence by design.
You leave with: DevSecOps reference architecture, evidence-ready pipeline blueprint.
Trusted by Technical Leaders
Delivering clarity and confidence in high-stakes environments.
Evidence Chain Readiness Checklist
A practical one-page checklist to assess your traceability, risk control mapping, and release evidence posture—before an auditor does.
- ✓ Requirements ↔ Risk ↔ Tests mapping questions
- ✓ Release evidence assembly check
- ✓ Pipeline evidence hygiene indicators
One-page PDF
No email required
Ready to transform your delivery?
Clarify your evidence gaps, risk hotspots, and practical next steps in a focused 30-minute conversation.
Book Your Discovery Call