Services
Fractional leadership, compliance and supplier oversight.
Everything below is delivered by me personally rather than a bench of associates.
Fractional software leadership
A software director on the days you need one.
Most early-stage device companies need a software director long before they can justify the full-time hire. I take the role on a fractional or interim basis and own it properly. The plan, the team, the budget, the suppliers and the board pack.
What it covers
- Software strategy and roadmap tied to regulatory and funding milestones
- Hiring and leading engineers, employed and contract
- Delivery planning, estimation and progress reporting the board can act on
- Build-versus-buy and in-house-versus-outsource decisions with costed options
- Supplier selection and day-to-day management
IEC 62304 and ISO 13485 compliance
Gap analysis through to an audit-ready software file.
I've developed software under IEC 62304 up to Class C inside ISO 13485 quality systems, with IEC 81001-5-1 covering secure development. Engagements run from a gap analysis with a prioritised fix list through to authoring the full documentation set and supporting the audit itself.
What it covers
- Gap analysis against IEC 62304, ISO 13485 and IEC 81001-5-1
- Safety classification and software development planning
- Software architecture and design documentation
- Requirements management and traceability, including ALM and document control tooling such as SpiraPlan and Veeva Vault
- Verification and validation strategy and evidence
- Audit preparation and support on the day
Supplier oversight
Technical ownership of outsourced development.
A lot of device software and firmware is written by external suppliers, and the standard makes the manufacturer responsible for it regardless. I act as the technical owner on your side. Interface definition, joint planning, review of the supplier’s lifecycle outputs and acceptance of deliverables against IEC 62304.
What it covers
- Supplier evaluation and technical due diligence
- Interface and integration ownership between in-house and supplied software
- Review and acceptance of supplier documentation and evidence
- Escalation and course correction when quality drifts
Fixed scope, fixed price
The IEC 62304 gap assessment.
The fixed-scope starting point. Two weeks, one product, one codebase.
£7,500 fixed, plus VAT.
Book the assessmentI review your software file and development process against IEC 62304, with ISO 13485 and IEC 81001-5-1 touchpoints, sanity-check your safety classification, and interview your technical and quality leads. You get a written report with a prioritised remediation plan, presented on a call, within five working days of the last interview.
The price is the price, and the report is yours to hand to your board, your investors or your notified body.