As a leading validation and testing laboratory, we now focus primarily on the increasingly complex and highly regulated world of reusable medical devices that require cleaning, packaging and sterilization procedures to complete their instructions for use. HIGHPOWER has been serving the medical, dental, pharmaceutical, and industrial industries for 30 years now.
With a broad global customer base and extensive regulatory experience with the FDA and regulatory bodies around the globe, our knowledgeable team works diligently to provide full-service support to our clients throughout each phase of device design, validation and regulatory approval. We proudly work with medical, dental, pharmaceutical and industrial industries around the world. 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.
We are an ISO 17025 accredited laboratory and have every major FDA cleared sterilization process (in our corporate facility) to perform a wide range of verification, validation and testing services.
Please feel free to contact us at clientservices@highpowervtls.com with any questions you may have.