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
Some of the ISO 13485 certification benefits
Organizations that can benefit the most
Certification process Step-by-Step