The Food and Drug Administration (FDA) is continually revising the current good manufacturing practice (CGMP) requirements for medical devices and incorporating them into a quality system regulation. The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. This action is necessary to add preproduction design controls and to achieve consistency with quality system requirements worldwide. This regulation sets forth the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.

HDH Inspect is a highly credentialed independent metrology laboratory. As such, we are committed to not only maintaining our certifications but also maintaining an up-to-date knowledge base on current good manufacturing practice (CGMP). Continuing to educate our lab technicians and quality engineers is a priority. Our highly educated technicians and engineers ensure that we're performing at the best of our ability and to the latest standards required by the FDA on behalf of our clients. With our exacting standards, we have been able to achieve a 100% project success rate the first time, every time.