Development strategy & design controls
We help organisations establish development structures that support decisions and evidence rather than simply create documents.
Typical assignments
- Intended-purpose, user-needs and design-input workshops
- Development-plan and design-control remediation
- Design-review readiness and decision-gate definition
- Traceability strategy and design-history-file assessment
ISO 13485FDA design controlsEU MDR
Systems & software engineering
We translate product intent and risk into coherent system and software requirements, architectures, plans and lifecycle records.
Typical assignments
- Software development and maintenance planning
- Safety classification and segregation rationale
- Architecture, interface and requirements review
- Lifecycle evidence reconstruction and gap closure
IEC 62304Systems engineeringConnected devices
Verification & validation
Plans and protocols should demonstrate that the right questions have been answered—not merely that testing happened.
Typical assignments
- System and software V&V strategy
- Risk-informed test planning and coverage assessment
- Requirements-to-test traceability
- Protocol and report review or remediation
VerificationValidationTraceability
Safety risk management
We connect foreseeable hazards and use errors to engineering controls, verification and residual-risk decisions.
Typical assignments
- Risk-management plans and reports
- Hazard analysis and FMEA integration
- Risk-control requirement derivation
- Essential-performance and benefit-risk rationale
ISO 14971IEC 60601IEC 62366-1
Product cybersecurity
Security becomes manageable when it is integrated into architecture, risk, development and post-market processes.
Typical assignments
- Threat modelling and cybersecurity risk assessment
- Security architecture and requirements baselines
- SBOM, VEX and vulnerability-management processes
- Cybersecurity plans, reports and regulatory evidence
IEC 81001-5-1FDA cybersecuritySBOM
Independent review & project recovery
When a project has become difficult, an experienced independent view can separate the urgent from the merely untidy.
Typical assignments
- Focused technical or submission-readiness assessment
- Prioritised remediation roadmaps
- Supplier and outsourced-development oversight
- Interim technical leadership and decision facilitation
Gap assessmentAudit readinessProject recovery
