Expert on Medical Devices

Sheila Ramerman, RAC, Principal SJR Associates 3684 N. Shasta Loop Eugene OR 97405 USA Phone: +1 541.683.3017 Email: sramerman@sjrassoc.com Web: www.sjrassoc.com

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.

Please visit our website at www.sjrassoc.com to view a list of products and technologies we have worked with.