Mark Furth

CEng FIMechE

About FERMI Medical Engineering

FERMI Medical Engineering is a specialist consultancy dedicated to regulatory excellence in medical devices and software. I am a Chartered Engineer and elected Fellow of the Institution of Mechanical Engineers, with 23 years of hands-on experience developing complex active and electro-mechanical medical devices — principally in radiotherapy and oncology technology.

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

The Queen's Award for Enterprise: Innovation recognised the Agility MLC — a multileaf collimator for radiotherapy beam shaping that I conceived and led from initial concept through design, development, production, and full lifecycle management. The Agility remains the highest-specification MLC available today, with best-in-class leaf speed and resolution, and continues to lead the market it defined.

Delivering it required coordinating a peak team of 28 engineers across mechanical, optical, electronics, software, and clinical disciplines; translating direct clinical stakeholder input into verified engineering specifications; and creating a novel optical tracking system for real-time closed-loop positional control of 160 independently actuated leaves. Serviceability, manufacturability, and long-term reliability were embedded as core design objectives from the outset — a discipline validated by sustained field performance across a global installed base.

My areas of expertise include: EU MDR/IVDR (Medical Device Regulation and In Vitro Diagnostic Device Regulation), UKCA strategy, FDA 510(k)/De Novo/PMA (the three main FDA routes to market approval), ISO 13485 (requirements for a quality management system), IEC 60601-1 (safety and essential performance requirements for active medical devices), ISO 14971 (medical device risk management), technical documentation, clinical evaluation, PMS (Post-Market Surveillance) and audit readiness. I am also currently formalising IEC 62366 (usability engineering and human factors) and IEC 62304 (software lifecycle) capability, drawing on direct experience leading teams that applied both disciplines.

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 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.