Quality Management System Medical Devices

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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.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

 

How can ISO 13485 help my business grow?

Voluntarily conforming to ISO 13485 is the best approach that companies have to prepare for an international market access.

Being ISO 13485 certified provides stakeholders and business partners with the confidence that the organization has put all the efforts to conform to the standard.

 

Benefits of ISO 13485

  • Improve your company's credibility and image
  • Improve customer satisfaction
  • Improve your processes
  • Improve decision-making
  • Create a culture of continual improvement
  • Better employee engagement.
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