446 Charnelton St, 97401 Eugene
Description of SJR Associates
SJR Associates is a medical device regulatory affairs, quality assurance, and clinical studies consulting firm. We specialize in point-of-care screening and diagnostic devices, and have experience with US FDA 510(k) submissions for Class I and II devices, with Canadian medical device licenses and submissions for Class I, Class II, and III devices, with European Union/CE marking requirements, and with Asia/Pacific Rim medical device registration/licensing requirements. We also have extensive experience with start-up and small companies in the following areas:defining and implementing successful regulatory strategies for fastest time to regulatory submission AND to market launch.
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