HIGHPOWER Validation Testing & Lab Services Inc. (HIGHPOWER) has been validating reusable medical devices for device manufacturers for over 25 years. HIGHPOWER initially specialized in the validation testing of sterilizers but quickly expanded into testing a multitude of other class II medical devices. HIGHPOWER’s validation laboratory was started by Gary Socola who continues as our current President today.
HIGHPOWER’s testing services focus mainly on reusable medical devices that require cleaning, packaging and sterilization between patients. Test protocols and final reports follow the most current national or international standards, are tailored to each device, and have a long history of acceptance by the FDA during a 510K review.
We strive to offer full service support prior to, during, and after device testing is completed. Having past experience as a class II medical device manufacturer and contract sterilization company ourselves, we have extensive knowledge to help support medical devices during the FDA 510K review process.
HIGHPOWER is an ISO 17025 accredited laboratory and is ASP factory trained to perform STERRAD® functionality and efficacy validation testing. We provide a wide range of verification, validation and testing services, as well as consulting services to medical device manufacturers.
With every major FDA cleared sterilization process (Ozone not available) in-house, we are available to assist device manufacturers in all of their verification/validation or regulatory compliance needs.
If you would like to discuss a test not currently listed on our website or have any questions in regards to our testing services, please contact us through the Contact Us link on this website.