Testimonials

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

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

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

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

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

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