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
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