ISO 13485 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 requirements and regulatory requirements applicable to medical devices and related services.
Organizations involved in medical device industry see ISO 13485 as the de facto standard towards regulatory compliance.
ISO 13485 certification (also known as “registration”), is a third-party audit performed by a certification body who, upon verification that an organization is in compliance with the requirements of ISO 13485, will issue an ISO 13485 certificate. This certification is then maintained through regularly scheduled annual surveillance audits by the registrar, with re-certification of the Medical Devices Quality Management System performed on a triennial basis.
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