The quality management standard for organizations involved in the design, production and servicing of medical devices.
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 consistently meet customer and regulatory requirements.
Built around risk management and regulatory compliance, it is the globally accepted benchmark for the medical-device industry and a frequent prerequisite for market access.
A medical-device QMS that ensures safety, compliance and access to regulated markets.
Align with medical-device regulatory requirements worldwide.
Embed risk management across the entire product lifecycle.
Meet a key prerequisite for selling devices internationally.
Reassure healthcare providers, regulators and patients.
Maintain rigorous records, documentation and traceability.
Continually improve quality and reduce nonconformities.
The core areas your organization will address on the path to ISO 13485 certification.
A transparent, impartial route from application to certification — and continual improvement beyond.
We scope your needs and review your current system against ISO 13485.
Readiness review followed by the full certification audit by qualified auditors.
An independent review and decision, then your certificate is issued.
Periodic surveillance audits and three-yearly recertification keep you compliant.
Talk to our team for a free, no-obligation assessment of your readiness for ISO 13485 certification — usually within one business day.