What is ISO 13485:2016?

Medical Devices-Quality Management Systems Safety and Quality are non-negotiable in the medical devices industry because service lapse could impact human lives. In this regard, ISO 13485 establishes requirements for comprehensive quality management for the design and manufacturing of medical devices. Implementing and maintaining a robust quality management system (QMS) for your medical devices, products and services provides an indispensable foundation on which to build your business. ISO 13485 certification of your QMS demonstrates your commitment to operating at a Global standard.

The ISO 13485:2016 certification process includes on-site audits to verify the capability and reliability of your quality management system. Our experts assess both the practical application and degree of effectiveness in the areas of design, development, production and customer care.

As a well-respected and globally recognized Certification Body, we hold extensive accreditations and are able to serve you at regional facilities worldwide. Our one-stop-shop portfolio consists of comprehensive services designed to accommodate your unique circumstances and business needs.

Optimize your MDQMS to the global standard of excellence!

Benefit

-Improved company’s reputation as the certified organizations perceived as self-conscious and responsible for the quality of medical devices manufactured for its customers.

-Improved and stronger decision-making based on established facts & figures demonstrated the safety of the produced medical devices

-Better compliance with regulatory requirements and ensured customer satisfaction