ISO 13485:2016 is the quality standard stating the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices.
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. 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 the 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 accreditation with IAS and IOAS, and our close links with the medical authorities enable us to meet your certification requirements effectively. In some countries, certain local certification is required ISO Certification for Medical Devices along with ISO 13485 medical devices in order to be eligible to manufacture and sell medical equipment. Our vast network of experienced auditors all over the world helps you achieve this certification in a time-bound and hassle-free manner.
ISO 13485 Benefits
Since ISO 13485 is an internationally recognized standard, building your MDQMS in accordance with it has unfathomable benefits for your organization. It tremendously reduces your costs. Some of the many benefits of ISO 13485 certification are listed below: