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We operate globally through our associate offices in
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ISO 13485 (QMS - Medical Devices Quality Management Systems)

ISO 13485 (QMS - Medical Devices Quality Management Systems)

ISO 13485 is the most accepted global standard for quality management in the medical device industry. It is issued by the International Organization for Standardization (ISO) and is considered as an ideal solution to meet the extensive requirements for a quality management system in the medical device sector.

The ISO 13485 standard characterizes discrete specifications needed for a quality management system needed by medical device organizations around the world. The certification is implemented where a corporation requires to manifest its capability to offer medical devices and related services that constantly meet customer and appropriate regulatory requirements.

Benefits of ISO 13485:
  • Improves efficiency, cut costs and monitor supply chain performance
  • Escalates access to more markets worldwide with certification
  • Shows that the business produces safer and effective medical devices
  • Outlines how to review and improve processes across your organization
  • Regulatory meets requirements and customer expectations
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ISO 90001 ISO 14000 ISO 27000 ISO 45000 ISO 55000

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