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ISO 13485:2016 certification for the design and manufacturing of medical devices
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Published on 3 Jan, 2019
Winmate obtains the latest Medical Device Quality Management Systems Standard
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ISO 13485:2016 certification for the design and manufacturing of medical devices

Winmate has obtained ISO 13485:2016 and EN ISO 13485:2016 quality management system certification for the design, development, production, installation, and servicing of medical 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 medical manufacturing certification that Winmate had been accredited with.
Winmate Certificate ISO 13485

ISO 13485 is a quality management system standard specifically for the medical devices industry. It was written to support medical device manufacturers in designing quality management system that establish and maintain the effectiveness of their processes. It ensures consistency from design to delivery of medical 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 medical industry.
 
Winmate Medically Certified Products:
 
10.1-inch Medical Tablet
10.1-inch Medical Tablet
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4K UHD Display
4K UHD Display
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Multi-touch Chassis Display
Multi-touch Chassis Display
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Winmate Medical News:
 
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New Winmate 15.6-inch Medical Multi-touch Display for Diagnosis and Clinical Review
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New Winmate 15.6-inch Medical Multi-touch Display for Diagnosis and Clinical Review
Why Certified-Safe Devices Are Important in the Medical Field
Winmate ISO 13485:2003 and EN ISO 13485:2012 certification for its design, development, production...
Why Certified-Safe Devices Are Important in the Medical Field
 
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