IPC2U's long-term partner Winmate announces that it has received the ISO 13485: 2016 and EN ISO 13485: 2016 certifications regarding the quality management system for the design, development, production, installation and maintenance of medical devices. This means that all Winmate tablets or displays that have been developed for use in the medical industry comply with the latest legal design requirements and are intrinsically safe. This recertification updates and replaces the previous certifications for medical manufacturing according to ISO 13485: 2003 and EN ISO 13485: 2012, with which Winmate was accredited.
The IPC2U GmbH would like to express its congratulations on this and looks forward to further cooperation with Winmate in the healthcare sector and elsewhere, especially in these difficult times, when preventing the spread of the new corona virus and the care and treatment of patients suffering from Covid-19 gain a lot more importance.
ISO 13485 is a standard for quality management systems especially for the medical device industry. It was designed to help medical device manufacturers develop a quality management system that determines and maintains the effectiveness of their processes. It ensures consistency from design to delivery of medical devices and confirms that they can be used safely for the intended purpose.
At Winmate, the quality management system is based on a process approach that enables the consistency of product service and support to be maintained. Winmate strives to develop products that meet all applicable legal requirements and at the same time are flexible enough to adapt to the requirements of technology and industry. ISO 13845 certification provides industry validation of Winmate's processes, products and approaches for the medical industry.
Learn more about IPC2U's extensive product range in the fields of healthcare, care and medical technology at: Medical PC