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.
- Study Design
- Protocol Development
- Project Management
- Report Prep
Our expertise can optimize your path to regulatory approval.
- Strategy Development
- Submission Prep
- MDD to MDR
- MDR Gap Assessment
Our regulatory experts can accelerate the complex device-to-market process.
- Clinical Evaluation
- PMCF Plans/Reports
- Regulatory Submissions
- Clinical Protocol, Study Reports
Our team’s extensive background coupled with excellent writing skills results in your document success.
- ISO 14971, 14155, 13485, 14971
- Clinical Evaluation, PMCF
- MDR Regs and Tech Docs
- IEC 62366 Usability
Our biostatisticians can develop a study design, set up a data base, analyze your results and prepare reports for all agencies.
- QMS Development
- Review and revision of QMS
- Right sizing QMS
Our Quality services are tailored to help you achieve your goals.
- QMS audits
- Supplier audits
- Clinical Quality audits
- SDLC audits
Our experienced team can support you through the entire audit process.
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.
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?
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.
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.
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.
How to Focus on Clinical Risk Management
Clinical research requires careful attention to risk in every aspect. We're all familiar with terms such as "Significant Risk Device," "risks outweigh the benefits," and “benefit-risk,” especially as risk relates to patients. This is important of course, but what...
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,...
MedTech MVP Conference 2022
Our CEO, Karen Bannick McQuoid, MA, RAC, FRAPS is attending the Medtech MVP conference in Minneapolis, MN June 14-15. She is looking forward to hearing some great discussions on neuromodulation (Jill Schiaparelli , MBA, Avation Medical) and medtech clinical trials...
We are your subject matter experts!
We're Here To Help!
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