ISO 13485 Certification

ISO 13485:2016 is the quality standard stating the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices.

ISO 13485 is a recognized international standard for quality management systems in the medical device business. It assures that organizations involved in the design, development, manufacturing, storage, distribution, installation, and servicing of medical devices comply with regulatory requirements and maintain the highest quality standards.

The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the norms of the ISO 13485 medical devices standard. ISO 13485 is a set of standards that helps in the implementation of the Quality Management System for Medical Devices (MD-QMS).

It demonstrates the competency of the organizations in delivering good quality and safe medical devices and relevant medical services that can fulfill the customer’s requirements as well as ensure compliance with the regulatory norms. The latest version of ISO 13485 Certification was published in 2016 and hence, it is termed ISO 13485:2016.

ISO 13485 certification involves building a quality management system for medical devices by identifying potential risks and documenting them effectively. The threats may arise from contamination of equipment or errors during handling. ISO 13485 provides for analyzing those threats and planning appropriate actions to prevent those risks.

Our vast network of experienced auditors all over the world helps you achieve this certification in a time-bound and hassle-free manner.