Winmate has obtained ISO 13485:2016 and EN ISO 13485:2016 quality management system certification for the design, development, production, installation, and servicing of healthcare devices. This means that any Winmate displays or tablets that are developed for use in the medcal industry are intrinsically safe and meet all the latest regulatory design requirements. This recertification updates and supersedes the previous ISO 13485:2003 and EN ISO 13485:2012 healthcare manufacturing certification that Winmate had been accredited with. |
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ISO 13485 is a quality management system standard specifically for the healthcare devices industry. It was written to support healthcare device manufacturers in designing quality management system that establish and maintain the effectiveness of their processes. It ensures consistency from design to delivery of healthcare devices, and confirms they are safe for use for their intended purpose.
At Winmate, our quality management system is based on a process approach, which allows us to maintain consistency in product service and support. We are dedicated to creating products that meet all applicable regulatory requirements, while remaining nimble and flexible enough to evolve with technology and industry need. ISO 13845 certification offers industry validation of Winmate's process, products and approach to the healthcare industry.
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