HIGHPOWER Validation Testing & Lab Services Inc. (HIGHPOWER) has been serving the medical device community for over 30 years. Initially focused on sterilizer validations, our testing quickly expanded into other class II and III medical devices. 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.
With a broad global customer base and extensive regulatory experience with the FDA and regulatory bodies around the globe, our knowledgable team works diligently to provide full service support to our clients throughout each phase of device design, validation and regulatory approval. 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 to perform a wide range of verification, validation and testing services, as well as consulting services to medical device manufacturers.
We look forward to working with you, please visit highpowervtls.com or contact us at [email protected]
Company’s Keywords:
device cleaning, reusable device testing, sterilization efficacy, asp factory trained in sterrad testing, iso 11607 package integrity testing, accelerated, real time aging shelf life, dry time studies, materials compatibility, human factors studies
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