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Testimonials

What Our Clients Have to Say

“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.”

– Darren DeMerritt, Director of RA/QA, ReNu Medical

“Nelson said your protocols were “very well written” and “extremely clear”…you’re awesome!”

– Founder, Orthopedics Company

“I highly recommend this firm as an excellent source for regulatory strategy and approval, biocompatibility assessment and strategy, product / project risk management, etc. for all stages of product development through product realization. The firm is ISO 13485 registered. Personally, I’ve utilized QA Consulting for the past 6 years for sterilization validations, biocompatibility assessments, and internal audits and QMS strategy. I have been most pleased with the knowledge, output and responsiveness of the staff.”

– Senior Quality Assurance Director

“I just got done with the document training with Stephanie and it was EXTREMELY helpful.”

– CEO

“QA Consulting has the background and experience to provide excellent validation services. Their knowledge in sterilization and packaging validation provided me with a protocol that met the FDA IDE requirements without a single question.”

– COO

“Anne is one of the more sensible / practical medical device quality gurus that I have had the pleasure of working with.”

– Tasha Bond, COO, Sana Health, Inc.

“Approvals are coming in from Health Canada. We have 3 out of 4 approvals as of just now without a single question. Thanks again for all of your help on this effort!”

– Director of Sterility Assurance

“Anne, my personal thanks to you for all the work you did. Your input on very short notice from the beginning and your mastery of a very complicated situation was absolutely critical in achieving settlement.”

– Partner and Attorney at Law

“Anne, you did an amazing job in an incredibly short amount of time and we are truly grateful to you for your work.”

– Partner and Attorney at Law

“Sallie McLaughlin is the resident biocompatibility expert and all around rock star!”

– Mechanical Design Engineer

“After 4 days the FDA auditor couldn’t find anything to write up. According to my coworker, she tried! I don’t expect any issues because I have the BEST microbiologist on my side!”

– Medical Device Manufacturer

“The FDA had no questions related to the sterilization validation and we received our US clearance… (two weeks post submission). Thanks for your help!”

– Director of Regulatory Affairs

“I wanted to let you know we will be receiving our certification to ISO 13485:2003! The notified body was impressed by QA Consulting’s process map. Thanks a lot for your help.”

– CEO

“I’m truly impressed with the work. I am almost certain that we will be contacting you for additional assistance.”

– Joe Lessard, Hardware Manager, NeuroStar

“Anne, thank you so much. It was really valuable to have you and Laura onsite for our audit.”

– Director of Quality Assurance and Regulatory Affairs

“I highly recommend Anne Wilson and her firm, QA Consulting, Inc. as an excellent source for regulatory strategy and approval, biocompatibility assessment and strategy, product/ project risk management, etc. for all stages of product development through product realization. Personally, I’ve used QA Consulting for the past 6 years for sterilization validations, biocompatibility assessments, internal audits, and QMS strategy. I have been most pleased with the knowledge, output, and responsiveness of her staff.”

– QA Director

“I would like to express my sincere appreciation to you for all of your expertise and assistance in helping us through the arduous FDA update process. This was such a very important achievement… and opens all the doors for us in our forthcoming marketing activities. Thank you so much for all your efforts on our behalf.”

– Neurosurgeon

“Thanks Sallie, It was a pleasure to work with someone who is good at what they do and uses common sense. Hopefully we can work with each other again.”

– Principle Partner

“Thanks for the quick response… It’s not often the case with auditors, but I would enjoy another visit from you in the future. Thanks again for a great audit!”

– Quality Assurance Manager

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