The development work is moving—but the evidence is falling behind.
We restore the links between decisions, outputs and objective evidence.
Independent technical consulting
Medical devices. Done right.
Senior guidance for safer products, stronger evidence and confident development decisions—from intended purpose to verification and release.
Working within the standards that shape modern medical-device development
ISO 13485ISO 14971IEC 62304IEC 81001-5-1IEC 62366-1IEC 60601
When to call us
Complexity is rarely the real problem.
The harder issue is often uncertainty: unclear inputs, disconnected evidence or a programme moving faster than its technical foundations.
Requirements, risks and verification no longer tell the same story.
We find the breaks, establish priorities and rebuild usable traceability.
An audit, submission or design review is approaching.
We assess what is defensible now and what must be addressed first.
Software obligations are unclear or inconsistently applied.
We translate lifecycle requirements into practical plans and evidence.
Cybersecurity is separate from the development and risk processes.
We integrate security risks, controls, architecture and post-market work.
You need an independent view before committing more resources.
We provide experienced judgement without a predetermined larger engagement.
Our standard
What “done right” means in practice.
It is not perfection, paperwork or process for its own sake. It is the disciplined use of evidence and judgement to make the right development decisions at the right time.
Clear foundations
Intended purpose, user needs, architecture and requirements that create a coherent basis for development.
Connected evidence
Visible relationships from risks and design inputs through implementation, verification and residual-risk decisions.
Proportionate control
Processes appropriate to the device, organisation and actual risk—applied with competence rather than ceremony.
Expertise
One technical story, not isolated disciplines.
Our work connects development, safety, software, verification and cybersecurity so the evidence makes sense as a whole.
01
Development strategy & design controls
Structure programmes around intended purpose, risk and the evidence required at each decision point.
↗ 02Systems & software engineering
Define coherent requirements, architectures and lifecycle controls for complex connected devices.
↗ 03Verification & validation
Build risk-informed plans, protocols and traceability that answer the right questions.
↗ 04Safety risk management
Connect hazards, sequences of events, controls and verification throughout the lifecycle.
↗ 05Product cybersecurity
Integrate threat modelling, security controls, SBOM, vulnerability management and post-market evidence.
↗ 06Independent review & project recovery
Find the gaps that matter, define a practical route forward and help teams regain control.
↗A defined starting point
Begin with a focused technical assessment.
Before recommending a larger assignment, we establish what is actually happening, which gaps matter most and what a proportionate recovery plan looks like.
- Frame the questionClarify the product, programme stage and immediate decision.
- Review the evidenceSample the essential documents, records and relationships.
- Identify material gapsSeparate consequential risks from presentational noise.
- Set the route forwardProvide prioritised actions, owners and decision points.
We do not add process for its own sake. We help you establish the controls, decisions and evidence your device genuinely needs.
Independent thinking. Practical implementation. Clear technical reasoning your team can understand and defend.
What needs to be put right?
Tell us where the programme stands, what decision is approaching and where confidence is lowest.