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  • ISO 13485 certification
    What is ISO 13485? ISO 13485 is a quality management system standard that is specific to the medical device industry. It helps manufacturers create products that are safe and effective for patients. To receive ISO 13485 certification, a company must demonstrate that it has a comprehensive quality management system in place. This system includes processes for the design, development,...
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  • iso 13485 certification
    ISO 13485 Certification: Ensuring Quality in Medical Devices ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry. It sets out the requirements for an organization’s ability to provide medical devices and related services that consistently meet customer and regulatory demands. ISO 13485 certification is a critical step for...
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