125 Highpower Road
Rochester, NY 14623
United States
We have extensive regulatory experience with the FDA and regulatory bodies worldwide. 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 510(k) review. HIGHPOWER Labs 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.