Services
My background is in complex active and electro-mechanical medical devices — systems that combine mechanics, electronics, software, and clinical performance requirements. That depth spans the full product journey: translating customer and clinical need into engineering specification, using risk analysis to drive better design, and building the quality and regulatory foundation to bring it to market.
Requirements and specification engineering
Turning what customers and clinicians actually need into engineering specifications that a design team can build to — the foundation every downstream regulatory and design decision depends on.
Direct customer and stakeholder requirements capture · translation into verified engineering specifications · requirements traceability through design and verification · specification review and gap analysis.
Regulatory strategy and approvals
Which pathway does your device need, and how do you build the case to get there — Europe, UK, US, or software as a medical device?
EU MDR/IVDR and UKCA pathways · FDA 510(k), De Novo and PMA strategy · SaMD classification · regulatory roadmapping · Notified Body and FDA engagement · submission authoring
Quality systems and risk
The quality processes and risk documentation regulators expect — built to scale as your business grows.
ISO 13485 implementation, gap closure and scaling · ISO 14971 risk management · design controls and DHF/DTF · internal audits, supplier qualification and audit readiness.
Design innovation through risk analysis
Risk analysis doesn't have to stop at identifying a problem. Used actively, it can drive the design decisions that solve it — turning a compliance challenge into a genuine product advantage. This is the approach behind the Elekta Agility MLC and other MLC product developments, where in-depth FMEA and use of other risk tools work led directly to patented design solutions and resolved significant regulatory challenges in the optical system. I bring the same methodology to Fermi client engagements — using risk analysis not just to document issues, but to actively shape the design response.
Technical documentation and clinical
The technical evidence that proves your device is safe and performs as intended — prototype through post-market.
Technical files and design dossiers · clinical evaluation plans and reports · verification and validation strategy · IEC 60601-1 compliance support (electrical safety, mechanical safety, essential performance) · PMCF and PMS planning · vigilance and remediation support
Also in active development: IEC 62366 usability engineering and IEC 62304 software lifecycle capability, informed by direct experience leading teams applying both.