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ISO 13485 Certification | Medical devices - Quality management systems

ISO 13485:2016 Certification

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ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. 

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

Main Benefits of having ISO 13485

  • Ensuring legal compliance

  • Lessens operational cost

  • Meet regulatory requirements

  • Gain competitive advantage

  • Improves customer satisfaction

  • Ensuring customer satisfaction

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Not sure if this certificate is for you?

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