ISO 13485 Medical Devices Quality Management System Certification - iCertWorks
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ISO 13485:2016 Medical Devices Quality Management System

Certification

ISO 13485:2016 Medical Devices Quality Management System

ISO 13485:2016 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.

Top 3 Management System standards that can be integrated with ISO 13485

  • ISO 37301
  • ISO/IEC 27001
  • ISO 9001

Some of the ISO 13485 certification benefits

  • Improved legal and regulatory or contractual requirements compliance
  • Increased Efficiency
  • Quality ensured medical devices
  • Safe and effective medical devices
  • Boost of loyal customers and potential customers

Organizations that can benefit the most

  • Companies that reprocess medical devices
  • Hospitals that service or reprocess medical devices
  • Consultants that provide technical services in design and development
  • Companies that provide sterilization services

Certification process Step-by-Step

  • Stage 1
    • Review of the Medical Devices-QMS
      • MSECB will conduct a review of the Medical Devices-QMS to look for the main form of documentation
  • Stage 2
    • Audit is performed
      • An audit is performed by us to verify that your organization is in conformity with the requirements of the standard
  • Stage 3
    • Certification is granted
      • Upon verifying that your organization is in conformity with the requirements of the standard, a Management System Certification is granted

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