ISO 13485:2016 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS CERTIFICATION

ISO 13485 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 requirements and regulatory requirements applicable to medical devices and related services.

Organizations involved in medical device industry see ISO 13485 as the de facto standard towards regulatory compliance.

Benefits of ISO 13485 certification to your organization:

  • Global Recognition
  • Improved legal and regulatory or contractual requirements compliance
  • ISO 13485 Medical Devices Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards
  • Assistance in monitoring supply chain effectiveness
  • Increased profit margins
  • Improved product safety
  • Increases Efficiency
  • Proactive error detection and prevention
  • Cost Savings
  • More Effective Risk Management
  • Increased likelihood of meeting Customer Requirements
  • More Effective Risk Management
  • Increased likelihood of meeting Customer Requirements

Benefits of ISO 13485 certification to your customers:

  • Quality ensured medical devices
  • Safe and effective medical devices
  • Lower skepticism and increased confidence for end-customer
  • Boost of loyal customers and potential customers
  • Increased profit margins

MSECB is specialized in the certification of management systems on a wide range of international standards. As a global provider audit and certification services, MSECB offers its expertise on multiple fields, including but not limited to Medical Devices Management.

INTI.Q mission is to provide our clients comprehensive services that inspire trust, continual improvement, demonstrate recognition, and benefit society as a whole. To find out how you can obtain the ISO 13485 Certification, contact [email protected]

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