Your Strategic Partner in Medical Device Approvals

Bannick provides clinical, regulatory, quality, auditing and medical writing consulting services to the medical device industry to help them get their product through regulatory approvals and to market.

We are your subject matter experts!


What We Do

Our services help you get safe and effective medical devices to market and keep them there.

Clinical Affairs

Optimize your path to regulatory approval by leveraging our unparalleled clinical affairs and development expertise.

Regulatory Affairs

Increasingly complex regulatory requirements and rapidly evolving technology can create headaches for medial device developers and we can help you navigate this complexity.

Medical Writing

Our team’s extensive clinical and regulatory background coupled with excellent writing skills results in having a talented professional medical writer on your team!

Quality System

Our Quality services are tailored to your needs so we can help you achieve your goals.


We perform Technical File, Clinical Study, Internal, Supplier, and Process audits for clients.


Medical Device Product Development Consulting

Our team at Bannick Primary are subject matter experts ready to tackle any aspect of medical device product development, including advising development teams on strategy, clinical study design, and market approval in the US and EU.

Medical Device Development

Every Team Member Plays A Part in Fulfilling Our Primary Purpose

The Bannick team is made up of industry-leading experts who care deeply about helping medical device companies achieve success and improve lives.

Would you like to be part of that?

Meet the Team


What People Are Saying

Karen has a strong understanding of not just CERs, but the regulations behind them and that is so important. She said that some vendors have processes to spit out CERs without worrying about regs, future audit questions and such: but that’s not Bannick.

Return Client

I have been fortunate to have Karen help several of my clients. Her skills, which combine regulatory, clinical, and statistical strategy, are world-class. Karen is my first choice resource for crafting clinical protocols we want to bring to FDA. She knows today’s landscape.

Amy Fowler


I’ve won the lottery—building our team of the best clinical and regulatory professionals who are simply stellar human beings. One more reason to stick with my commitment to getting the right people in the right seats rather than growing as fast as we can and training the staff at our client’s expense. Thanks to each member of our Bannick team for your honorable service and to our future clients for your patience.

Karen Bannick McQuoid

Owner & CEO, Bannick LLC

We are your subject matter experts!

We're Here To Help!

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