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.


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.


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.


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.