ISO13485

Medical devices have a direct impact on human life and health, so they must ensure a higher level of stability than any other product. Therefore, the medical device industry must meet domestic regulatory systems, international standards and other requirements.
In order to meet the requirements of the EU Medical Device Directive, a quality system must be established, and some countries, such as Canada, require ISO 13485 certification for product sales. With ISO 13485 system certification, A manufacturers who manufacture medical devices can demonstrate that their system meets the comprehensive requirements for quality management systems and the specific requirements for medical devices.

This standard helps following

· IGC has been accredited for ISO 13485 by UAF, KAB, an Accreditation Body in the United States, and provides certification services for quality management systems.

· The auditors of IGC are contributing to the continuous development of customers by accurately assessing the suitability of the medical device quality management system through the technology and expertise accumulated over the years.

· As a trusted global leader in management system certification, IGC offers ISO 13485 certification as well as CE and FDA.

· IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.