Polhemus is a Good Manufacturing Practices (GMP) Contract Manufacturer under U.S. FDA Regulations. We are not a manufacturer of Medical Devices. Polhemus systems are not certified for medical or bio-medical use. Any references to medical or bio-medical use are examples of what medical companies have done with the Products after they have obtained all necessary or appropriate medical certifications. The end user/OEM/VAR must comply with all pertinent FDA/CE regulations pertaining to the development and sale of medical devices and all other regulatory requirements.