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contextflow, the Viennese expert for machine learning in radiology, has been successfully certified by TÜV Süd according to ISO 13485:2016. "With this certification, we have proven we fulfil all requirements for a comprehensive quality management (QM) system for the design, production and marketing of medical devices," says Co-founder and CEO Markus Holzer. The company paid particular attention to the safety precautions for storing patient-related data during the design of the QM system.
To confirm compliance with ISO 13485:2016, TÜV Süd carried out two audits at contextflow in September 2019. In the first stage, the notified body assessed whether the company had established all processes required by the standard. The second stage dealt with the details of the individual processes and the fulfilment of the defined tasks. The scope of the certificate covers the design, development, production and distribution of artificial intelligence-based software solutions for radiological diagnostics. The certificate is valid for three years and is confirmed every year after a successful audit.
"The main focus of our quality management system is on meeting customer requirements and striving to exceed customer expectations," says Nilaykumar Patel, Quality Affairs Manager at contextflow. "It provides us with a platform to communicate the needs and expectations of customers throughout the organization and to take these expectations into account when developing medical devices and services." An essential part of this process is to provide employees with the necessary resources, training and authority to act responsibly. For this reason, risk management, handling of customer feedback, post-market surveillance and corrective and preventive measures are precisely defined.
Last but not least, contextflow’s QM system supports the implementation of the Deming PDCA cycle (Plan Do Check Act). "This enables us to achieve optimised performance through effective process management, efficient use of resources and reduced cross-functional barriers, as well as to better understand the current and future needs and expectations of the customers link them to contextflow’s objectives," Markus Holzer concludes.