ISO 13485 – Medical Devices 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 company:

  • 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
  • Increased Efficiency
  • Proactive error detection and prevention
  • Cost Savings
  • 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

ISO 13485 certification (also known as “registration”) is a third-party audit performed by a certification body such as PECB MS who, upon verification that an organization is in compliance with the requirements of ISO 13485, will issue an ISO 13485 certificate. This certification is then maintained through regularly scheduled annual surveillance audits by the registrar, with re-certification of the Medical Devices Quality Management System performed on a tri-annual basis.


Contact us to find out how we can assist you in attaining ISO 13485 Certification.