ISO 13485:2003 is an international standard, which enables organizations to implement a Quality Management System aimed at the medical device industry, by establishing a quality policy, controls and risk management.

The "ISO 13485:2003 and GMP - ISO 14971 - Risk Management are complementary and should be used together in addition it is important to know:
• Differences between ISO 13485:1996 and ISO 13485:2003 Interpretation of ISO 13485:2003 Implementation of Quality Management System based on ISO 13485:2003 Presentation of ISO / TR 14969:2003-WD2 The relationship between management Risk and ISO 14971:2001 The ISO 13485:2003 X GMPs

Medical devices comprise an enormous complexity of products, products that need to be regulated and supervised care for all involved. When referring to medical devices we're talking about all the equipment involved in health and are in one way or another helping the medical industry to treat the patient, medical devices are provided by the scalpel diagnosis apparatus such as a simple device X-ray to an MRI machine.

The complexity is such that in Europe there are several published guidelines to explain the regulation of the sector. The main thing is MDD - Medical Device Directive, which explains the requirements for each medical device. The CDC has counterparts in Brazil, which are almost identical, and facilitate the international regulation of such products.

Few specialists in this area in terms of ISO 13485 certification in Brazil. The Brazilian market has yet to show the colors, as there is, it does not appear in international fashion, making sure, for example, in ISO 13485. The next step after certification in ISO 13485 is the CE - European Conformity.