An international standard that sets out the requirements for a quality management system for organizations that design, manufacture, manufacture, install and service medical devices, as well as for those who use spare materials or components used in these medical devices.

The ISO 13485 standard was developed based on the ISO 9001 standard, they share the same basic principles, however the ISO 13485 standard additionally requires a large portion of mandatory documentation and highlights issues such as work environment, risk management, design control processes and regulatory requirements.

The European version of the standard (EN ISO 13485) is accompanied by updated information attachments that establish links with the European Directives (EC Directives):

- European Medical Device Directive (MDD) 93/42 / EEC

- European In-Vitro Diagnostic Directive (IVDD) 98/79 / EC

- European Active Implant Directive (AIMD) 90/385 / EEC

ISO 13485 also establishes a model to ensure compliance with other regulatory bodies worldwide.

There is a growing demand from medical equipment manufacturers and service providers for their products and services to be certified in accordance with ISO 13485 as a prerequisite for doing business.

ISO 13485 Certification is also important to differentiate your organization from competitors and improve compliance with market requirements.