Engineering expertise
with regulatory built in.
Whether you need a development partner from day one, someone to own the technical pathway, or a specialist for a specific hard problem — we work at the intersection of medical device engineering and regulation.
For companies that need engineering and regulatory expertise throughout development — not just at submission. We work alongside your team from concept through to technical file, embedding compliance into design decisions rather than retrofitting it at the end.
This is a collaborative engagement. We're in your design reviews, your risk workshops, and your verification planning. You build the device; we make sure it's built to be approved.
For companies that want us to take responsibility for the technical development pathway. You own the product vision and the manufacturing; we own the regulatory and technical development strategy, documentation, and submission readiness.
We take the complete technical risk burden — standards applicability, design controls, risk files, V&V protocols, and technical documentation — off your plate and deliver a submission-ready package.
For companies that already have a development team but need specialist expertise for a difficult technical or regulatory problem. IEC 60601-1 clause interpretation, IEC 62304 software classification, ISO 14971 FMEA methodology, a failing test item, a notified body query that needs a precise answer.
Targeted engagements. No retainer required. We solve the specific problem and hand it back.
The standards expertise we apply across all three service types.
General safety and essential performance (60601-1), EMC (60601-1-2), usability (60601-1-6), alarms (60601-1-8), home healthcare (60601-1-11), emergency medical services (60601-1-12), and applicable particular standards.
Risk files built to ISO 14971:2019 — hazard identification, risk estimation, risk control, and residual risk assessment with clear traceability to verification evidence.
Software lifecycle documentation for Class A, B, and C medical device software. SDP, software architecture, unit and integration testing, SOUP management, and maintenance planning.
Usability engineering per IEC 62366-1 — use specification, task analysis, formative and summative evaluation planning, and use error risk analysis integrated with the ISO 14971 risk file.
Structured requirements engineering and design control documentation — from user needs to design outputs, with traceability matrices that satisfy both ISO 13485 and regulatory reviewers.
V&V protocol development, test method justification, acceptance criteria definition, and summary reports linking test evidence to design outputs and requirements.
Ready to get started?
Tell us about your device and we'll map out the path to market.
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