Committed to regulatory compliance

As an ISO 13485-certified and FDA-registered partner, we recognize the importance of regulatory compliance in medical device manufacturing. We share your commitment to and responsibility for compliance with regulatory requirements wherever your devices are marketed. Our systems are built with regulatory compliance in mind, from design and development to purchasing through manufacturing and record archiving. We strive to maintain a constant state of readiness for regulatory inspection by effectively executing our Quality Management Systems in all aspects of our business.