ISO 13485 MED: 2016

ISO 13485 specifies the requirements for a quality management system for companies providing medical devices and related services that meets regulatory standards.

What is ISO 13485 MED: 2016 ?

ISO 13485:2003 specifies the requirements for a quality management system for organizations who provide medical devices and related services to consistently meet customer requirements and regulatory requirements in the medical industry.

Adopting ISO 13485 provides a practical foundation for manufacturer to address the medical device directives, responsibilities, regulations as well as demonstrating a commitment to provide reliable quality and safety of medical devices.

Our Certifications

We help companies and organizations that are seeking to achieve certification standards such as ISO 9001, ISO 14000 and more through our comprehensive implementation model that includes tools and onsite training.