About Us

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.
		establishing quality systems without excessive bureaucracy.
		building responsive and compliant regulatory and quality functions in a start-up environment.