The threats may arise from contamination of equipment or errors during handling. ISO 13485 certification involves building a quality management system for medical devices by identifying the potential risks and documenting them effectively. The latest version of ISO 13485 Certification was published in 2016 and hence, it is termed ISO 13485:2016. 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. ISO 13485 is a set of standards that helps in the implementation of the Quality Management System for Medical Devices (MD-QMS). The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the norms of ISO 13485 medical devices standard.
