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ISO13485

ISO 13485

Medical Devices: Quality Management System – Requirements for Regulatory Purposes

Certification in accordance with ISO 13485 means that an organization is able to provide medical devices and related services that consistently comply with their customer and regulatory requirements.

Organizations may be involved in one or more stages of the life cycle, including the design and development, production, storage and distribution, installation and maintenance of a medical device, and the design and development or delivery of associated activities (technical support, for example).

ISO 13485 can also be used by providers and external parties that supply products, including services related to these organizations’ quality management systems.

Under ISO 9000 standards, guidelines aimed at the manufacture of Medical Devices were developed, including sector-specific requirements.

Consequently, certification in accordance with ISO 13485 aims to facilitate the implementation of regulations and community directives.

The main benefits of the implementation and subsequent certification in accordance with this benchmark include:

The systematic, integrated and coherent implementation of tools and procedures aimed at the manufacturing specificities of Medical Devices and associated services;

Compliance with all regulatory requirements for medical devices and related services;

Total control of the production and final destination of the products;

Increased consumer and customer confidence;

Access to new national and international markets.