Thanks very much from all of us for making this possible. We have our very first 510k and your guidance and experience when dealing with the FDA helped make this possible!”
Percy, President, Medical Device Manufacturer
We were pleased with the audit of the lab and are moving to put HIGHPOWER on our approved supplier list. You have an impressive array of sterilization technology available for testing, and we are looking forward to acquiring some sound steam sterilization validations from your lab.”
Chris, Sterilization Assurance Specialist, Medical Device Manufacturer
No non-conformances were noted during the audit. Observations included an extremely well-organized, knowledgeable staff who demonstrated dedication and attention-to-detail and a very well-established quality system. I would like to thank Jennifer and Don for their professionalism in planning and facilitation of the audit. HIGHPOWER Labs was a first-class organization whose employees treated me with the utmost courtesy during my visit.”
Stephen, Sterilization Assurance Specialist, Auditor, Third Party Quality and Compliance Registrar
HIGHPOWER is a well-organized and very capable facility with an excellent quality system. All equipment appeared to be in good operating order. QA/RA, Supervisors, and Technicians were very open and responsive to questions and providing demonstrations of the various areas within the validation process. HIGHPOWER is highly capable of providing validation testing services.”
Jose, Auditor, Medical Device Manufacturer
Don, I want to take a few moments to thank you, Gary, and your entire staff. The commitment level that you all showed in hosting the Human Factors study FAR exceeded my expectations. The professionalism that everyone exhibited once again proves to me, how fortunate I was to be guided to you as a testing facility and more.
“Again, I appreciate all the attention and hospitality that you have shown to us…”
Barry, Senior Vice President/Marketing, Medical Device Manufacturer