Engineering-led Design Assurance Support for Medical Device Development.

Fen MedTech helps teams turn complex R&D prototypes into defensible and robust devices.

Available for short and long-term project-based work.

How I Can Help Your Team

I bring structure to MedTech programmes where ambiguous requirements put verification and clinical timelines at risk. I bridge the gap between R&D and regulation by establishing the robust design controls and end-to-end traceability required for a defensible Design History File (DHF).

This includes:

  • Translating ambiguous user needs into clear, quantified, and testable system requirements for complex electromechanical and robotic platforms.

  • Defining risk-based verification and validation strategies for Class II and III devices, including surgical instruments, single-use consumables, and active implantables.

  • Developing and validating bespoke test methods and custom rigs to generate repeatable, scalable data for DHF submission-ready evidence.

  • Implementing manufacturing process validation, including IQ/OQ/PQ and characterisation studies for devices produced in ISO 7/8 cleanroom environments.

  • Conducting DHF remediation and gap analysis to ensure technical documentation meets ISO 13485, ISO 14971, and FDA 21 CFR Part 820 expectations.

  • Executing formal verification activities and performing statistical analysis to generate robust, audit-ready datasets.

Design Assurance & Regulatory Documentation

Supporting design control and traceability from concept to submission. I specialize in bridging the gap between R&D and quality to ensure technical files are audit-ready and compliant with ISO 13485 and FDA 21 CFR Part 820.

Test Development & Evidence Generation

Designing and validating bespoke test methods, custom rigs, and automated fixtures. I execute verification testing to generate the robust, defensible datasets required for critical design decisions and regulatory evidence.

Verification & Validation Strategy

Defining risk-based verification approaches for complex Class II and III systems. I ensure that system requirements, risk controls, and verification activities are fully aligned with ISO 14971 to de-risk clinical and regulatory milestones.

Manufacturing & Process Validation

Authoring and executing Validation Master Plans (VMP) and specific Validation Plans for complex manufacturing programmes. Providing hands-on support for IQ/OQ/PQ, process characterisation, and cleanroom readiness for medical device systems, including active implantable and surgical robotic environments.