We consistently continue to gain FDA product clearances, product CE mark for European entry, and ISO 13485 Quality Management System certification for our clients.  With over 37 years real-world industry experience, we understand the need to balance business growth and regulatory compliance. We are creative but practical in our approach to registration activities and quality management system construction. We are known for hands-on assistance with our clients during their ISO certification by successfully building and implementing a quality management system that is customized for their specific way of doing business. We have successfully guided medical device manufacturers through their premarket application process, and we are most proud of the novel technology devices that we help our clients clear through FDA and bring to market as quickly and smoothly as possible. We are experts at communicating with FDA when the new breakthrough technologies evoke reviewer questions.

Awards and Certifications