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Medical Device Consulting Services

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Industry Insight

October 14, 2020 in Regulatory Affairs, Standards

Five Steps to Get Your Medical Device to Market on Your CEO’s Timeline

Author: Anne Holland, CEO and Founder  CEOs can be demanding, I should know. Often, instead of working alongside their quality…
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October 5, 2020 in Featured: Regulatory Affairs, Quality Systems, Regulatory Affairs, Safety, Standards

Startup Series: A Medical Device Quality Standards Primer

Author: Anne Holland, CEO and Founder This article is the first in a series of blog posts designed to help…
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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!