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ISO 13485


ISO 13485

Prime Vision consulting for ISO 13485 certification for medical devices manufacturer in Delhi, ISO 13485 certification in India, ISO 13485 consultancy services for medical devices, ISO 13485 certification for medical devices exporters.

Details :
EN ISO 13485 is the international standard for quality management systems for medical devices. To get quality management practices for medical devices, focusing on design and development, production, customer service, and assembly. Benefit from the positive effects of a quality management system: lean processes, efficient work flows, and international recognition.


Benefits of ISO 13485 :

  • Improved legal and regulatory or contractual requirements compliance
  • Risk identification and management
  • Enhanced product safety
  • Proactive error detection and prevention


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