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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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U.S. FDA Strategy

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Post-Market Compliance

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Microbiology

Industry Insight

November 6, 2023 in Featured: Microbiology Analysis, Sterilization, White Paper

How to Avoid Dose Audit Failures and What to Do When It Happens to You

Author: Sallie McLaughlin, Principal Microbiology Consultant Understanding and Overcoming Sterility Test Failures in Medical Device Radiation Dose Audits Paying close…
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July 1, 2023 in 483s, Audits, Complaint Handling, FDA Inspections, Post-Market Surveillance

Medical Device Post-Market Compliance

Post-Market Compliance Strategy Expertise Once your medical device goes to market, it doesn’t mean you’re done with compliance. Medical device…
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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.

Jeff StarkPrincipal Process Engineer, CryoLife

QA Consulting, Inc. was instrumental in bringing CryoLife’s mechanical heart valves to market. Their expertise directly related to our devices enabled them to hit the ground running without extending our project timeline. They helped us reduce the engineering time needed and shortened our timeline for FDA approval. The quality and regulatory expertise of the QA Consulting team is unparalleled.

James B. Stiehl, MDFounder, Stiehl Tech, LLC

The close relationship I had with the QA team made for an easy process. As our company sought to commercialize a new medical device product, their knowledge and expertise helped us get the Perilav system to market.

Diane KeyserDirector of Quality Assurance, Eximis Surgical

What I appreciated is the breadth of services that QA Consulting, Inc. provided, including expertise with Grand Avenue Software. They offered quick and efficient QMS SOPs, and were pleasant to work with.