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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.
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An estimated 1 in 20 patients are affected by hospital-acquired infections (4.1 million patients every year)
– Source: WHOÂ
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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
Stage 1
Review of the Management System
MSECB will conduct a review of the Management System 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