Engineering-led regulatory excellence for advanced medical devices

FERMI Medical Engineering helps innovators in active and electro-mechanical medical devices navigate the approvals process — from customer requirements and risk-led design through to documentation, quality systems, and safety evidence, getting your device to market and keeping it there. Founded by a Chartered Engineer and Queen's Award for Enterprise: Innovation recipient with 23 years' experience in medical technology, I bring calm, precise guidance across the full product lifecycle — from concept to post-market.

Specialist services

Regulatory strategy and submissions

Understanding which approval pathway your device needs, and building the case to get there — whether that's entering the European, UK, or US market, or classifying software as a medical device:

  • European Medical Device Regulation or In Vitro Diagnostic Regulation: EU MDR/IVDR
  • UK Conformity Assessed strategy: UKCA
  • FDA submission to allow commercial distribution in the US:
    • Devices substantially equivalent to a legally marketed device - 510(k)
    • Novel new devices with low to moderate risk - De Novo
    • Devices that support or sustain life or substantial risk - PMA

  • Software as a Medical Device: SaMD classifications

  • Notified Body and FDA engagement
  • Gap analyses and remediation roadmaps.

QMS and risk management

Putting in place the quality processes and risk documentation that regulators and notified bodies expect to see — and making sure they scale as your business grows:

 

  • ISO 13485 implementation, gap closure and scaling;

  • ISO 14971 risk management;

  • Design History or Technical Files (DHF/DTF);

  • Internal audits, supplier qualification and audit readiness.

Technical documentation and lifecycle

Creating and maintaining the technical evidence that demonstrates your device is safe and performs as intended, from first prototype through to post-market — including active device safety standards, with usability engineering and software lifecycle capability currently in development.

 

Technical files and design dossiers, clinical evaluation plans and reports, verification and validation strategy, IEC 60601-1 compliance support (electrical safety, mechanical safety and essential performance), PMCF and PMS planning, vigilance and remediation support. (IEC 62366 usability engineering and IEC 62304 software lifecycle — in active development, informed by direct experience leading teams applying both.)