HIGHPOWER has been validating reusable medical and dental devices for over 30 years. We have undergone multiple 21 CFR Part 820, Quality Systems Regulation audits by the United States Food & Drug Administration and ISO 13485 audits by various notified bodies around the globe.
Each year, HIGHPOWER is audited by multiple medical device manufacturers, notified bodies, consultants, pharmaceutical and industrial customers for a thorough review of our validation and testing services. HIGHPOWER has been found to be in compliance with 21 CFR Part 820, ISO 17025 and ISO 13485 by all parties auditing.
Companies seeking audits of the HIGHPOWER facility can contact us by email at info@highpowervtls.com or by contacting us at 1-888-722-1529 and requesting to speak to our quality department at extension 1933.