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SJR Associates is a regulatory affairs consulting practice that specializes in medical devices and diagnostic products.  We have experience in worldwide medical device regulation, quality systems, clinical affairs, compliance, and electronic submissions. We provide comprehensive regulatory services in the following areas:

• Medical Devices
• Point-of-Care Devices
• In Vitro Diagnostic Devices

We have particular expertise with helping start-ups and small companies:

• define and implement successful regulatory strategies for fastest time to regulatory submission and to market launch
• establish quality systems without excessive bureaucracy
• build responsive and compliant regulatory and quality functions in a start-up environment

We provide a pragmatic, practical approach to regulatory, quality, and clinical functions that assists medical device companies in achieving their business goals, at a reasonable cost, in a time-efficient manner.