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Regulatory, quality and human factors expertise

Submission-ready support from consultants who have built QMS, supported submissions, and sat on both sides of the audit table.

Human FactorsRiskReg & Quality

Human Factors

Concept through summative validation.

Risk Management

Hazard to control to verification.

Regulatory & Quality

Strategy, documentation and QMS build-out.
Human Factors

Usability engineering & IEC 62366-1

Human factors programs built around your device, users and use environment, documented for FDA and EU MDR.

  • Concept, IFU and packaging review
  • Task analysis and critical tasks
  • Use-related risk analysis (URRA)
  • Formative studies
  • Summative / HF validation
Illustration of a usability study on a pen injector: a gaze path across the cap, dose window and dial, three finding cards, a fixation chart and a task timeline.
Hazard→Control→Verification
Risk Management

ISO 14971 risk files, tied to design

Use, process, design and software risks in one traceable chain, from hazard to control to verification.

Regulatory & Quality

Regulatory strategy, technical documentation and QMS build-out

510(k) · EU MDR · ISO 13485

Gap assessments, DHF structuring and audit-ready submission packages.

QMS build-out & audit readiness

Right-sized quality systems aligned to ISO 13485:2016 and US FDA QMSR, tested before your audit.

Contact

Tell us where you are in the process

We'll map out what comes next.