ISO 13485

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that meet customer and regulatory requirements.

The standard covers the quality system, not the clinical performance of a particular device. Typical processes are document control, training, design and development, purchasing, production, identification and traceability, complaints, internal audit, CAPA and management review. Certification is granted by a certification body after an audit. The certificate is not a marketing authorization.

MDSAP uses ISO 13485 as the quality-system backbone and adds regulatory tasks. FDA's QMSR aligns the US device quality-system regulation with ISO 13485. EU MDR does not replace ISO 13485, but notified bodies commonly expect a 13485 system underneath technical documentation.

HAVGATE audits ISO 13485 as a first-class standard and can combine it with MDSAP, EU MDR and QMSR in one session on Pro and above. The product does not issue an ISO 13485 certificate.