Our early MDR certification is an acknowledgement of the strength of our life-cycle approach to safety, backed by clinical data
Agfa HealthCare’s early certification allows the company to continue to expand the Enterprise Imaging platform, its modules and components, and release innovations without any interruption. This includes making significant changes to the solutions and adding new functionalities to meet the evolving needs of our customers and the market, as well as allowing them to benefit from state-of-the-art IT technologies.
Chris Ball, Head of Quality Assurance and Regulatory Affairs, comments, “Agfa HealthCare is compliant with the latest and most rigorous quality standards and certification requirements for medical devices in the world, and MDR certification will be an important qualification criterion. Supported by our clinical evaluation, risk management and quality management systems, our early MDR certification is an acknowledgement of the strength of our life-cycle approach to safety, backed by clinical data.”
“The early certification offers clear proof that Agfa HealthCare is committed and ready to be the long-term partner of choice to our customers,” says Luc Thijs, President of Agfa HealthCare.
Source: Agfa HealthCare
Source: Healthcare in Europe