Good Manufacturing Practices (GMP)

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.

Client Testimonials

Using Polhemus technology, NeuroScan was able to be the first in the industry to produce a three dimensional image of a subject's head and define the exact location of electrodes placed on the subject. "For the first time we can quickly take EEG data and overlay it on a MR image for an exact definition of where electrical activity is coming." Before using Polhemus solutions, this was a long and difficult process to accurately calculate this activity."

- Stephen Sands, Chief Scientist, Compumedics Neuroscan