![]() Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better work processes. Why is Medical Devices Quality Management System important for you?īeing an ISO 13485 certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal.
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