Defensible QA/RA systems, for audit, scale & investment.
I help MedTech teams move from “documented” to genuinely controlled (MDR, UKCA, FDA, SaMD)
Where teams typically get stuck
When Audits Are Approaching
Notified Body readiness
FDA inspection readiness
Risk management defence
When Scaling or Raising Investment
Due diligence preparation
Structural gap analysis
System maturity review
When Change is Constant
Change control integrity
End to end Traceability
Risk alignment
MDR & UKCA | SaMD & Active Devices | PRRC oversight | Audit readiness | Due diligence support