ISO 13485

An ISO 13485 is an international standard that specifies the requirements for Quality Management System (QMS) for medical device manufacturers and design.An effective QMS defined in ISO 13485 are aimed to design, manufacture as well as distribution of medical devices that are effective. This assures that organizations involved in the design, development, manufacturing, storage, distribution, and installation, of medical devices comply with regulatory requirements and maintain the highest quality standards.

The benefits ISO 13485 includes high prestige, employee involvement, customer satisfaction, makes company trustworthy, wider market reach, and enhanced product quality. Thenetwork of experienced auditors all over the world helps you achieve this certification in a hassle-free manner.