Skip to main content

Your innovation.
Our expertise.

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.


Learn More


Learn More


Learn More


quality system development icon

Quality System Development

auditing icon


FDA strategy icon

U.S. FDA Strategy

post market compliance icon

Post-Market Compliance

microbiological analysis


Industry Insight

June 28, 2023 in Uncategorized

EU MDR Requirements: Embracing a New Era of Compliance and Quality Assurance

EU MDR Overview The European Union Medical Device Regulation governs the safety, quality, and performance standards for medical devices marketed…
Read More
June 8, 2023 in Uncategorized

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…
Read More
newsletter icon

Device Discourse Newsletter

Register for our newsletter to receive relevant and thoughtful news and information about the medical device industry and happenings at QA Consulting.

Sign-Up Today
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.