NormiQ works with medical device manufacturers on the parts of a quality system that get tested every day — document control, CAPA follow-through, supplier oversight — rather than only the parts an auditor samples once a year.
Four principles shape every engagement.
The system threads through design control, change management, and training records — the everyday mechanics of running a device company, not a binder maintained alongside them.
Control comes from clear roles and accountability structures, not from the number of SOPs on file.
Readiness is tested through internal audit simulation and gap analysis before a regulator or Notified Body ever reviews the system.
Engagement scope is sized to the product's actual risk profile — a Class I device doesn't carry the same documentation load as a Class III implant.
Engagements extend past the audit — toward sustained operational maturity.