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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

Get our FREE article published in Quality Magazine on how to implement a risk-based QMS.



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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


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

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

    – Founder, Orthopedics Company
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  • 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. Continue Reading

    -Senior Quality Assurance Director
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  • 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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Latest News

  • Four Dangerous Myths about Quality that May Cost Lives

    Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known and appreciated, and that can cost lives. Conversely, when executives…

  • 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…

Company Credentials


Click on logos to download respective certificates.