HIGHPOWER is a leading validation and testing laboratory, focusing 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. 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. With every major FDA cleared sterilization process in-house, we are available to assist MDMs in all of their verification/validation and regulatory compliance needs.
If you’re faced with long delays and record requests for information from the FDA, you are not alone. Benefit from our experience as we become an extension of your team and help bring your device to market. Contact us today at (888) 722-1529 or info@highpowervtls.com
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