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!

SERVICES

What We Do

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

Clinical Affairs

Our expertise can optimize your path to regulatory approval.

Regulatory Affairs

Our regulatory experts can accelerate the complex device-to-market process.

Medical Writing

Our team’s extensive background coupled with excellent writing skills results in your document success.

Biostats

Our biostatisticians can develop a study design, set up a data base, analyze your results and prepare reports for all agencies.

Quality System

Our Quality services are tailored to help you achieve your goals.

Audits

Our experienced team can support you through the entire audit process. We perform Technical File, Clinical Study, Internal, Supplier, and Process audits for clients.

Approach

Medical Device Product Development Consulting

Our high-performing, adaptive 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

TESTIMONIALS

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

RAC, J.D.

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

IVDR – What Is A PER?

IVDR – What Is A PER?

Overwhelmed by all the challenges presented by the IVDR, such as new risk classification rules, expanded clinical evidence requirements or need for notified body approval where none was required previously? Experience with the implementation of MDR for medical devices...

EU MDR and How We Can Help

EU MDR and How We Can Help

Working feverishly on your EU MDR documentation in preparation for May 24, 2024 final implementation? Well, the MDCG has just offered you some insights into how to get there. Work harder. Need help? We would love to jump in! We are a full-service consulting firm,...

We are your subject matter experts!

We're Here To Help!

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Offices in FL & MN

Email Us

info@bannickprimary.com

Offices in FL & MN

Email Us

info@bannickprimary.com