VORTRAN Medical Technology 1, Inc. has engaged in an extensive research and development process to create the Pulmonary Modulation Technology (PMT), and an associated new line of fully automatic disposable respiratory devices for treating patients with pulmonary diseases in the hospital, and alternate sites (EMS,acute care, post-acute, homecare) market segments. VORTRAN Medical Technology1, Inc. is registered with the U.S. Federal Food and Drug Administration (FDA) and the California State Food and Drug Branch (FDB) as a medical device manufacturer. Annual audits by both the FDA and FDB ensure compliance with "Current Good Manufacturing Practice" (CGMP, 21 C.F.R. Code of Federal Regulation) and the Safe Medical Devices Act of 1990. The design of our devices is reviewed by the FDA as required by the 21 C.F.R. Section 510(k) to ensure that our devices are safe and efficacious. Consistent product quality is assured through our comprehensive Quality Assurance Program certified under ISO 13485:2003. Our goal is to exceed our customers' expectations and to provide products and service of the highest quality.
