Risk management
Our ISO 14971 risk file is a living document that informs design choices in every phase and is closed out in a risk management report.
Our approach
Structured, traceable, risk-driven
Our process mirrors the design control lifecycle, so the engineering and the evidence are produced together — not reconstructed at the end.
The five phases
From clinical need to production
Each phase ends with a design review gate. That gives you a clear picture of progress, and it gives reviewers and auditors a clear record of how decisions were made.
Principles behind every project
- Safety and effectiveness come first
- Every requirement is verifiable and traced
- Risk decisions are documented and justified
- Process is scaled to device class and stage
- Transparent communication at every gate
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1
Discover
We start by understanding the clinical problem, the intended use, the users and the use environment — along with your business constraints, timeline and regulatory pathway assumptions.
Typical deliverables: Project charter, intended use statement, user needs, preliminary hazard list
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2
Define
User needs are translated into measurable, verifiable design inputs. We build the design and development plan and establish the risk management plan and traceability structure.
Typical deliverables: Design & development plan, design input requirements, risk management plan, traceability matrix
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3
Design
Concepts are developed, prototyped and evaluated. Risk analyses (hazard analysis, dFMEA) are updated as the design matures, and formal design reviews confirm readiness to proceed.
Typical deliverables: Design outputs (drawings, specifications, software), dFMEA, prototype evaluation reports, design review records
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4
Verify & Validate
We plan and execute verification against every design input and support validation against user needs, including usability and standards-based testing.
Typical deliverables: V&V plans, protocols and reports, test method validation, usability engineering file, risk control verification
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5
Transfer
The design is prepared for repeatable production: DFM refinements, the device master record, process validation and supplier readiness. The DHF is closed out and the risk management report completed.
Typical deliverables: DMR, process validation (IQ/OQ/PQ), design transfer checklist, risk management report, complete DHF
Throughout the lifecycle
Continuous threads across every phase
Traceability
User needs, design inputs, outputs, risk controls and verification results remain linked so gaps are visible immediately.
Collaboration
Regular status updates, shared documentation and clear decision points keep your team informed and in control.
Have a device concept or a design challenge?
Tell us where your project stands. We'll reply with practical next steps — no obligation.