Customer Testimonials
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
I just wanted to extend our sincerest gratitude for the wonderful support you provided us with this past week. We were able to accomplish more than was planned due to your efficiencies and well organized lab. We realize that our request was not something commonly accommodated and greatly appreciate your willingness to help us in our efforts. Please know that we hold HIGHPOWER Labs in high regard with respect to your expertise, experience, and customer support. We look forward to future opportunities to rely on your lab for validation and test services.”
Chris, Manager, Sterilization Technology, 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
It is apparent that HIGHPOWER has a very mature quality system. When it comes to laboratories, I’ve been in many and HIGHPOWER is one of the best I’ve ever seen…”
Auditor, ISO 17025 Accreditation Body
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
Your team at HIGHPOWER were critical to this achievement. The hard work, determination, good advice and patience from your team helped us accomplish this 510k approval. We fully expect to work closely with HIGHPOWER on upcoming projects based on the very positive experience we have had.”
Adrian, Senior Manager, Medical Device Manufacturer
Great news on the Sterilizers! I can’t wait to start working with HIGHPPOWER on STERRAD® validation testing. For now we need to do some feasibility testing. Thank you so much for your help and please keep your fingers crossed for us with the new FDA person in charge of our 510k submittal.”
Jay, Product Manager, Medical Device Manufacturer
Thank you very much for returning the documentation so quickly! As I mentioned to Mike, the responsiveness of HIGHPOWER has been fantastic through the quoting process and working together thus far.
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Emily, Quality and Regulatory Manager
Thank you very much for spending time with us during our visit. Your new facility is very impressive and we would like to work together on future projects with HIGHPOWER.”
Roger, General Manager, Medical Device Component Supplier
Wonderful lab, I really appreciate your hard work and always speedy service! It has been great working with you.”
Nichole, Product Manager, Laboratory and Validation Peer