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We Deliver Comprehensive and Personalized Consulting Services to the Medical Device Industry

A Risk Based Approach to Medical Device Quality Management

Learn the differences between
ISO 13485:2016 and ISO 13485:2003

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Whether you need expert consulting advice or to completely outsource your quality and/or regulatory department, QA Consulting will tailor a solution to achieve your strategic goals.

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.
Learn more about our consulting capabilities

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.

    Read more
  • 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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Latest News

  • Risk Based Approach for Medical Device Quality Management

    Quality Magazine recently published an article “A Risk Based Approach For Medical Device Quality Management” written by Anne  Holland, CEO and Founder of QA Consulting, Inc. The team at QA Consulting…

  • QA Consulting, Inc. Presents at TMCx in Houston

    Recently one of our Consultants, Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant presented to the newest cohort of start-up medical device companies selected for the Texas Medical…

  • Tina Hudson Joins QA Consulting

    We are delighted to announce that Tina Hudson is joining the QA Consulting team as a Senior Quality Engineering Consultant. Her expertise includes all areas of quality system management with…

Company Credentials


Click on logos to download respective certificates.