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ISO 13485 Medical Devices Quality Management System Certification

ISO 13485 Medical Devices Quality Management System 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.

An estimated 1 in 20 patients are affected by hospital-acquired infections (4.1 million patients every year)

– Source: WHO 

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

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

Certification process Step-by-Step

Review of the Medical Devices-QMS

MSECB will conduct a review of the Medical Devices-QMS to look for the main form of documentation

Audit is performed

An audit is performed by us to verify that your organization is in conformity with the requirements of the standard

Certification is granted

Upon verifying that your organization is in conformity with the requirements of the standard, a Management System Certification is granted

Not sure where to begin? Start here.​

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