Medical Device Consulting Services
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Overview of the Different Types of FDA Inspections for Medical Devices
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Darren DeMerrittDirector of RA/QA, ReNu Medical
“Personally, I want to thank you a lot for your help throughout this process. With your guidance and expertise, you really pointed us toward the best path to be successful and I am extremely grateful for that. I hope that this was just the first of many projects that we have with QA Consulting.”
Tasha BondCOO, Sana Health, Inc.
“Anne is one of the more sensible / practical medical device quality gurus that I have had the pleasure of working with.”
Joe LessardHardware Manager, NeuroStar
“I’m truly impressed with the work. I am almost certain that we will be contacting you for additional assistance.”
Jeff StarkPrincipal Process Engineer, CryoLife
“QA Consulting, Inc. was instrumental in bringing CryoLife’s mechanical heart valves to market. Their expertise directly related to our devices enabled them to hit the ground running without extending our project timeline. They helped us reduce the engineering time needed and shortened our timeline for FDA approval. The quality and regulatory expertise of the QA Consulting team is unparalleled.”
James B. Stiehl, MDFounder, Stiehl Tech, LLC
“The close relationship I had with the QA team made for an easy process. As our company sought to commercialize a new medical device product, their knowledge and expertise helped us get the Perilav system to market.”
Diane KeyserDirector of Quality Assurance, Eximis Surgical
“What I appreciated is the breadth of services that QA Consulting, Inc. provided, including expertise with Grand Avenue Software. They offered quick and efficient QMS SOPs, and were pleasant to work with.”