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Medical Device Consulting Services

Medical Device Consulting Services

Your trusted partner for innovative medical device consulting services and outsourcing custom-designed to meet your objectives throughout the product lifecycle. Lean into quality with medical device systems everyone can trust.


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Quality System Development

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U.S. FDA Strategy

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Post-Market Compliance

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Industry Insight

December 10, 2020 in Featured: Microbiology Analysis, Microbiology, Standards

Tips for Developing Expert Medical Device Biological Evaluation Reports: Avoid These 3 Common Mistakes

Author: Amber Hilfiger, Director of Operations and Senior Engineering Consultant A biological evaluation report (BER) is a collective summary of…
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November 23, 2020 in News & Information

We Love Quality! (So you don’t have to)

The QA Consulting Team enjoyed a little online celebration to celebrate 20 years of success with a virtual toast from…
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Darren DeMerrittDirector of RA/QA, ReNu Medical

Personally, I want to thank you a lot for your help throughout this process. With your guidance and expertise, you really pointed us toward the best path to be successful and I am extremely grateful for that. I hope that this was just the first of many projects that we have with QA Consulting.

Tasha BondCOO, Sana Health, Inc.

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

Joe LessardHardware Manager, NeuroStar

I’m truly impressed with the work. I am almost certain that we will be contacting you for additional assistance.

Quality Assurance Manager

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!

Founder, Orthopedics Company

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

Director of Sterility Assurance

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!

Partner and Attorney at Law

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.

Principle Partner

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.

Director of Regulatory Affairs

The FDA had no questions related to the sterilization validation and we received our US clearance… (two weeks post submission). Thanks for your help!