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What is ISO 13485?

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ISO 13485 provides requirements particularly for the organization's quality management system to improve the quality of medical devices and equipment. This international standard enables the organization to provide medical devices that satisfy customers and applicable legal requirements. ISO 13485 is applicable to all sizes of organizations that develop and supply medical devices and equipment. The requirements of this standard are also intended to apply equally to associated services provided by organizations. ISO 13485 certification in Colombia3