Experts. Solutions. Results.

 

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.

Audits

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.

Microbiology

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
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Our Team

Testimonials

  • 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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  • 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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Company Credentials

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Click on logos to download respective certificates.