We design and manufacture components and finished devices that have a direct and positive impact on the lives of countless patients around the world. From our line workers to our design engineers, we hold ourselves to the highest standards of quality.
Our quality mantra is Quality Works Here. This summarizes our commitment to world-class quality in everything we do:
With 50+ years of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities. We host 100+ audits per year from customers and regulatory bodies.
Our certifications and registrations:
Our enterprise-wide quality policy and program are designed to ensure consistent high quality and compliance at every location, on every project, at every stage of the product lifecycle. Dedicated on-site teams ensure compliance with rigorous internal quality systems, some of which include:
Download our location-specific registrations and ISO certifications