Verification & Validation Engineering for Medical Devices

Helping MedTech companies accelerate medical device development through expert Verification & Validation engineering.

How I Can Help Your Team

I help MedTech teams develop robust verification strategies, validated test methods, and audit-ready design evidence that reduces technical, clinical, and regulatory risk.

This includes:

  • Translating user needs into measurable, testable system requirements for complex medical devices.

  • Developing risk-based Design Verification (DV) strategies aligned with ISO 14971 and Design Control requirements.

  • Developing, validating, remediating, and transferring test methods (TMV) that generate reliable, repeatable, and statistically justified data.

  • Designing bespoke test rigs, fixtures, and laboratory methods for mechanical, functional, environmental, and performance testing.

  • Supporting DHF remediation, verification traceability, engineering investigations, and root cause analysis.

  • Producing verification protocols, reports, statistical analyses, and regulatory evidence to support ISO 13485 and FDA submissions.

Test Method Validation & Verification

Developing, validating, remediating, and transferring test methods for complex medical devices. Designing bespoke test rigs and executing Design Verification to generate robust, repeatable, and statistically defensible evidence.

Design Verification & Engineering Investigations

Planning and executing Design Verification activities, engineering investigations, root cause analysis, and verification reporting to demonstrate product performance against design requirements.

Verification Strategy & Statistical Justification

Developing risk-based verification strategies, protocols, and traceability. Supporting sample size justification, Gage R&R, statistical analysis, engineering investigations, and verification reporting.

Manufacturing & Process Validation

Supporting manufacturing readiness through Validation Master Plans, IQ/OQ/PQ, process characterisation, equipment qualification, test method transfer, and technology transfer for regulated medical device manufacturing.