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Human Factor Testing | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/services/human-factors
Protocols & Procedures. Education & Consulting. Protocols & Procedures. Education & Consulting. Biological & Chemical Indicator Testing. Repeat Cycling/Limits of Reuse Testing. ISO 17025 Certificate of Accreditation. HIGHPOWER’s test methodology is based on methods outlined in ANSI/AAMI HE75. Some reusable medical devices require human factors testing in order to assure proper and safe use by health care personnel. With multiple healthcare facilities in the area, HIGHPOWER has a deep pool of hospital par...
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ISO 17025 Accreditation | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/quality-certifications/iso-17025
Protocols & Procedures. Education & Consulting. ISO 17025 Certificate of Accreditation. HIGHPOWER conformed to the requirements of the United States Food and Drug Administration’s 21 CFR Part 820, Quality Systems Regulations for the first 25 years of our existence. In 2014 we became accredited to the ISO 17025 quality standard. Testing and calibration laboratories that comply with this International Standard also operate in accordance with ISO 9001. HIGHPOWER’s ISO 17025 Scope of Accreditation. Functiona...
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Packaging System Validation | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/services/packaging-validation
Protocols & Procedures. Education & Consulting. Protocols & Procedures. Education & Consulting. Biological & Chemical Indicator Testing. Repeat Cycling/Limits of Reuse Testing. ISO 17025 Certificate of Accreditation. HIGHPOWER’s test methodology is based on methods outlined in ISO 11607, AAMI ST-77 and the FDA guidance document Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA . With every major FDA clear...
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Press Releases | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/about/press-releases
Protocols & Procedures. Education & Consulting. HIGHPOWER Letter to AAMI Regarding FDA Steam BI Requirements. August 6, 2015. HIGHPOWER Labs Purchases State-of-the-Art Getinge Steam Sterilizer. June 12, 2015. HIGHPOWER Labs Adds Equipment to Assist with Device Cleaning Validations. January 7, 2014. New Name and Facility for Medical Device Validations. February 28, 2013. Industries Proudly Served by HIGHPOWER. Standard Terms and Conditions. ISO 17025 Certificate of Accreditation. August 6, 2015. HIGHPOWER...
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Protocols & Procedures | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/services/protocols-procedures
Protocols & Procedures. Education & Consulting. Protocols & Procedures. Education & Consulting. Biological & Chemical Indicator Testing. Repeat Cycling/Limits of Reuse Testing. ISO 17025 Certificate of Accreditation. Protocols & Procedures. Devices and test samples submitted to HIGHPOWER are tested in accordance with American or International standards, FDA guidance documents, internal written laboratory standard operating procedures, device specific validation protocols or study plans, as are appropriate.
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Events | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/events
Protocols & Procedures. Education & Consulting. HIGHPOWER will be attending the following events in 2016, please contact Don Tumminelli at dtumminelli@highpowervtls.com. If you would like to set up a meeting to discuss any potential validation services or current projects. April 2-6, 2016. April 18 21, 2016. August 2-4, 2016. October 26-29, 2016. October 17 20, 2016. 888) 722-1529 Toll free. M – Th: 8 am – 5 pm EST. Fri: 8 am – 4 pm EST. 125 Highpower Road,.
highpowervtls.com
Device Cleaning Validation | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/services/cleaning-validation
Protocols & Procedures. Education & Consulting. Protocols & Procedures. Education & Consulting. Biological & Chemical Indicator Testing. Repeat Cycling/Limits of Reuse Testing. ISO 17025 Certificate of Accreditation. Device cleaning procedures must be able to remove gross amounts of soil from the device in order for it to be determined clean and safe for further processing. HIGHPOWER’s device cleaning program verifies that gross amounts of soil can be removed from the test device following the recomm...
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Biocompatibility Testing | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/services/biocompatibility-testing
Protocols & Procedures. Education & Consulting. Protocols & Procedures. Education & Consulting. Biological & Chemical Indicator Testing. Repeat Cycling/Limits of Reuse Testing. ISO 17025 Certificate of Accreditation. We’re constantly adding new test to meet our customer’s expectations. If you don’t see your required biocompatibility test listed, please contact us at info@highpowervtls.com. 888) 722-1529 Toll free. M – Th: 8 am – 5 pm EST. Fri: 8 am – 4 pm EST. Functionality and efficacy validation testin...
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Repeat Cycling/Limits of Reuse Testing | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/services/repeat-cycle-testing
Protocols & Procedures. Education & Consulting. Protocols & Procedures. Education & Consulting. Biological & Chemical Indicator Testing. Repeat Cycling/Limits of Reuse Testing. ISO 17025 Certificate of Accreditation. Repeat Cycling/Limits of Reuse Testing. HIGHPOWER’s test methodology is based on methods outlined in AAMI TIR 12, AAMI TIR 17, ANSI/AAMI ST79 and other sterilization specific national and international standards. Let us validate that your device, and the materials it is comprised of, are com...
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Industries Proudly Served by HIGHPOWER | HIGHPOWER Validation Testing & Lab Services
http://highpowervtls.com/about/industries-served
Protocols & Procedures. Education & Consulting. Industries Proudly Served by HIGHPOWER. Standard Terms and Conditions. ISO 17025 Certificate of Accreditation. Industries Proudly Served by HIGHPOWER. Each customer, depending on their industry or trade may have different test requirements and validation needs for their products or devices. HIGHPOWER recognizes and understands these unique circumstances and develops individual test and/or services tailored to meet each customer’s specific needs.