CAPA — Corrective and preventive action

The quality system process for investigating problems, eliminating their causes and preventing recurrence. Corrective action is defined in both regulations; the combined CAPA term comes from quality management practice rather than from the regulations themselves.

Reference: MDR Article 2(67); IVDR Article 2(70)

QMS — Quality management system

The documented system through which a manufacturer ensures ongoing compliance, proportionate to risk class and device type. The regulation lists the aspects it must cover, including regulatory compliance strategy, risk management, clinical evaluation or performance evaluation, product realisation, post-market surveillance and vigilance.

Reference: MDR Article 10(9); IVDR Article 10(8)