Regulated delivery that produces a coherent evidence chain.
The goal is straightforward: enable confident release decisions by maintaining traceability from intent to evidence. This approach supports regulated expectations (e.g., ISO 13485 design controls, IEC 62304 software lifecycle, ISO 14971 risk management), while remaining pragmatic for real engineering teams.
Systems lifecycle overview
Each stage is designed to produce and maintain specific artefacts, linked through traceability.
Requirements
Intent, acceptance, constraints
Risk
Hazards, controls, residual risk
Design
Architecture, interfaces, rationale
Implementation
Controlled changes, reviews
Verification
Tests, coverage, evidence
Release
Package, traceability, sign-off
Risk & compliance integration
Principle
Risk is not a document “at the end”. Risk controls are engineered into requirements, design, and verification from the start.
What this prevents
Last-minute remediation, missing justifications, uncontrolled changes, and weak audit narratives.
What you can expect
• Clear definitions of intended use and system boundaries
• Consistent linkage between hazards, controls, and verification evidence
• Design rationale captured as decisions are made (not reconstructed later)
• Evidence packaging that supports release decisions
Traceability and design controls (explained plainly)
Traceability is treated as an engineering property of the system: each requirement and risk control has a clear path to design elements and verification evidence. This supports design controls expectations without drowning teams in manual administration.
Requirements
Quality-focused: testable, unambiguous, and tied to acceptance criteria.
Risk controls
Explicitly mapped: where the control lives (design/process) and how it’s verified.
Verification
Evidence-oriented: tests exist to prove controls and requirements, not just to increase coverage.
The evidence chain
This is the story an auditor expects to see—quietly, consistently, and without gaps.
intent + acceptance
hazard + control
architecture + rationale
verification evidence
traceability + sign-off
CI/CD quality gates aligned to regulated expectations
Automation is used where it strengthens evidence quality and repeatability.
Quality gates (examples)
• Controlled change process and peer review discipline
• Build provenance and repeatability
• Automated test execution and evidence capture
• Security checks appropriate to risk (dependency scanning, SBOM where relevant)
• Release readiness checklist linked to traceability
What “good” looks like
A release can be explained quickly: what changed, why it changed, which risks were affected, and what evidence supports acceptance. The evidence is generated as part of delivery, not assembled under pressure.
For practical examples, see Engagement Highlights. To understand where this fits your organisation, review Services.