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It’s vital to meet FDA and ISO 13485 Standard quality and reliability requirements for medical ventilators and other medical equipment. But there’s still more that ventilator OEMs need to put into practice, specifically in the high reliability or Hi Rel area to further add to ISO 13485. The term “Hi Rel” is most often associated […]

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Covid-19 continues to dominate the news around the world.  Medical experts aren’t sure when this deadly virus will subside or whether or not it’ll return again even stronger.  But one critical fact remains.   There continues to exist a great demand for medical ventilators, not just for now, but also in the future to effectively deal […]

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For EMS providers and contract manufacturers, the International Standards Organization (ISO) 13485 Standard provides a considerable number of challenges. They all fall under the main category of quality management systems for medical electronics products. But now there is a new wrinkle associated with ISO 13485; this wrinkle isn’t in the books and is rarely spoken […]

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ISO 13485 is about potential risks involved and mitigating them during and after the building of medical products. It is a specific ISO standard serving as a comprehensive management system for the design and manufacture of medical devices. Like other ISO standards, its focus is on continuous improvement in process and quality systems. Also, a […]

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