About FERMI Medical Engineering

FERMI Medical Engineering is a specialist consultancy dedicated to regulatory excellence in medical devices and software. We are led by a Chartered Engineer and Queen’s Award for Enterprise: Innovation recipient with 23 years of hands‑on experience across radiotherapy, imaging, interventional and diagnostic technologies.

Our approach is calm, precise and evidence‑led. We align design controls with clinical intent, craft robust risk files, and build pragmatic quality systems that scale. We partner with founders and R&D leaders to de‑risk programmes, accelerate approvals and uphold patient safety.

Expertise: EU MDR/IVDR and UKCA strategy, FDA 510(k)/De Novo/PMA, ISO 13485, ISO 14971, IEC 62304 (SaMD), technical documentation, clinical evaluation, PMS and audit readiness.

FERMI Medical Engineering takes its name from Enrico Fermi — the physicist whose foundational work on nuclear reactions and radiation physics underpins the cancer treatment technologies I spent 23 years helping to develop.

That career — shaping radiation beams for oncology treatments, from engineer to engineering leader — gave me something that most regulatory consultants do not have: a deep, hands-on understanding of what it actually takes to design, build, and validate a complex electro-mechanical medical system.

FERMI also stands for Fellowship Engineering Risk Management Intelligence — reflecting my credentials as a Chartered Engineer and elected Fellow of the Institution of Mechanical Engineers, and the core disciplines I bring to every client engagement.

The name is deliberate. It says something about where I came from, what I know, and how I work.