We can proudly announce that our company has successfully passed the audit for the ISO 13485:2016 – Quality Management System for Medical Devices. The certificate was granted for the “design, manufacture, and sale of a medical device in the form of software supporting genetic diagnostics”.
ISO 13485 specifies the way a company implements quality management system that focuses on safe and effective products. It also demonstrates organization’s ability to provide software as medical device and related services that consistently meet applicable regulatory requirements as well as customers’ needs. There are certain elements that are especially crucial in the ISO 13485 structure (besides Quality Management System itself): Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement.
ISO 13485:2016 certification gives us a good foundation for expanding our business. By obtaining this quality accreditation, we ensure that our products are designed and delivered to the highest standards as a part of a fully controllable process.