A risk management strategy is essential when developing and manufacturing medical devices.

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    Training is matched to each client’s needs for integration of quality related practices.

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    QA Consulting offers a comprehensive range of microbiological services.

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    We offer design control solutions from concept through design transfer.

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Experts. Solutions. Results.


“Over the last 15 years, I have carefully cultivated a team of experts for QA Consulting who share integrity and enthusiasm for our work. I have handpicked each member of our staff for his or her diverse experience within our industry, as well as attention to detail. I can say with certainty that our consultants collectively provide unparalleled customer service as well as unique and creative solutions to all of our clients, regardless of the scope of their project or budget.”

-Anne Holland, CEO and Founder

Quality Systems

We are fully equipped to serve as an outsourced quality department, creating and implementing a customized quality system for each client.


Our auditors are ASQ Certified Quality Auditors or Exemplar Global Lead Auditors. We provide the required independent and objective party for quality system audits.

Regulatory Affairs

We provide support through the entire product lifecycle, such as defining regulatory pathways, managing regulatory submissions, and assessing labeling and design changes.


Our consulting team utilizes national and/or international standards to derive microbiological requirements from the concept phase throughout validation and the regulatory approval process.

Our Team


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

    -Mechanical Design Engineer
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  • 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
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  • 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 Continue Reading

    -QA Director
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  • 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.

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  • 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
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Company Credentials


Click on logos to download respective certificates.