Quality standards in the medical device industry always start with ISO 13485, 9001 and the FDA’s Quality System Regulation guidelines. In conjunction, EirMed institutes our own additional quality guidelines to govern every step of our medical device manufacturing processes. By meeting these standards, our team can provide assurance for every device we manufacture.
The FDA’s QSR and each ISO certification are a framework of standards that manufacturers must follow by developing and implementing procedures. It’s our duty to enact and adhere to strict quality standards specific to the medical device solutions we provide.
The focus of our quality policy is to maintain effectiveness, continuously improve and conduct effective training. By coordinating our quality policy along with ISO and FDA guidelines, we can ensure every employee at EirMed has the tools to achieve the highest possible quality in every job performed.
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To learn more about our quality assurance practices, and how they fit into the larger framework of medical device manufacturing, request a consultation with one of our experts.