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
- Study Design
- Protocol Development
- Project Management
- Report Prep
Our expertise can optimize your path to regulatory approval.
Regulatory Affairs
- Strategy Development
- Submission Prep
- MDD to MDR
- MDR Gap Assessment
Our regulatory experts can accelerate the complex device-to-market process.
Medical Writing
- Clinical Evaluation
(CEP/CER/CDP) - PMCF Plans/Reports
- Regulatory Submissions
- Clinical Protocol, Study Reports
- Manuscripts/Abstracts
Our team’s extensive background coupled with excellent writing skills results in your document success.
Training
- ISO 14971, 14155, 13485, 14971
- Clinical Evaluation, PMCF
- MDR Regs and Tech Docs
- IEC 62366 Usability
Biostats
Our biostatisticians can develop a study design, set up a data base, analyze your results and prepare reports for all agencies.
Quality System
- QMS Development
- Review and revision of QMS
- Right sizing QMS
Our Quality services are tailored to help you achieve your goals.
Audits
- QMS audits
- Supplier audits
- Clinical Quality audits
- SDLC audits
Our experienced team can support you through the entire audit process.
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.
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?
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.
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.
IVDR – putting all the pieces together
And just like that, a year has passed and we witnessed the IVDR roll-out. At the outset, IVDR may appear to be a simple guidance for IVD products, however, there are subtle nuances that help decide the regulatory strategy for these devices. Important takeaways from...
IVDR is now live, are you ready?
The May 2022 “Date of Application” for in vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR) has come and gone! Do you have a good grasp of the IVDR jigsaw for CE certification? Don’t juggle all the puzzle pieces without a strategic plan for compliance...
Do you need a clinical audit?
Each year, FDA publishes their bioresearch monitoring (BIMO) inspection metrics from the previous year. Like clockwork, inspectional findings issued by the agency contain similar themes: failure to follow the investigational plan, inadequate monitoring, and issues...
We are your subject matter experts!
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