Regulatory excellence for advanced medical devices
FERMI Medical Engineering is a premium regulatory compliance consultancy for innovators in medical technology. Founded by a Chartered Engineer and Queen’s Award for Enterprise: Innovation recipient with 23 years in device development, we bring calm, precise guidance across the full product lifecycle — from concept to post‑market.
Specialist services
Regulatory strategy and submissions
EU MDR/IVDR and UKCA strategy, FDA 510(k), De Novo and PMA pathways, SaMD classifications, Notified Body and FDA engagement, gap analyses and remediation roadmaps.
QMS and risk management
ISO 13485 implementation and optimisation, ISO 14971 risk files, design controls and DHF/DTF, internal audits, supplier qualification and audit readiness.
Technical documentation and lifecycle
Technical files and design dossiers, clinical evaluation and PMCF planning, verification and validation strategy, post‑market surveillance and vigilance.