Why Bannick LLC?

We are passionately engaged in this industry and thrive on our contribution
to the health and safety of patients around the world!

About Us

Medical Device Consulting Since 1998

Our team of experts at Bannick Primary, including 4 PhD’s on staff, can develop your regulatory strategy, clinical study design and clinical evaluation for the US, EU and beyond. Each of our experts has demonstrated ability to provide strategic clinical, quality, and regulatory and reimbursement guidance to medical companies. When you need guidance working with regulatory agencies to negotiate submission strategy, preparing the quality management systems, clinical protocols and regulatory submissions, and looking ahead to reimbursement, we truly have “been there, done that.”

Why Choose Us

We are committed to high standards when it comes to our work process and product.

We are mindful of confidentiality. We focus on what, who and why.

We exemplify integrity, loyalty, competency and commitment.

We have a primary purpose...more than getting it done. We have a mindset of doing it well and with intention.

Our Primary Purpose

Our primary purpose is to contribute to a healthy and balanced life for our team, our clients and patients by providing strategic direction and document development to bring medical devices to global markets.

Our Core Values

We exemplify integrity, loyalty and competency.
We do it well and with intention.
We are mindful of confidentiality.
We focus on what, who and why.

Maintaining Our Primary Purpose

We primarily do this by offering companies of all sizes industry-leading regulatory and quality support. And that’s just the beginning…

Industry Experts

PhD's on Staff

CER & PMCF Plans and Reports

Team

Meet Our Executive Team

Karen Bannick McQuoid | Owner & CEO

Karen Bannick McQuoid
RAPS Fellow Logo

Karen Bannick McQuoid is the owner and CEO of Bannick LLC, a primary device group founded in 1998.  Her team includes medical device experts that provide clinical (and CER writing), quality, regulatory and reimbursement guidance to medical device companies.  Karen became committed to “returning man to full life” during her first week at Medtronic, when Earl Bakken presented her with her medallion.  Driven by that passion to bring technology to patients around the world, Karen has practiced her unique combination of biostatistics, clinical study experience and exceptional regulatory skills in the medical device industry for over 30 years, partnering with Fortune 500 companies, small companies and start up medical device companies bring their Class II and III products to market in the US, Europe and internationally.

Karen’s experience makes her an enthusiastic and insightful advisor.  She has prepared multiple US (PMAs, IDEs, and 510(k)s) and European submissions (MDD, AIMDD and MDR).  Since MedDev 2.7.1 Rev 3, she has authored over 100 clinical evaluation reports, including 7 to the MDR with no major nonconformities.  She excels when tackling a complex project requiring strategic insights from several angles.  She and her team at Bannick LLC deliver high quality, efficient and timely results.  Her experience encompasses cardiology, neurology, pain management, wound care, urology, chronic pain, sleep apnea and vascular.

She has a BA in biostatistics, MA in Health and Human Services Administration, and an MA in management.  Karen is RAC certified and a Fellow of the Regulatory Affairs Professional Society (RAPS). She is Past President of the American Medical Writers Association (AMWA) North Central Chapter and volunteers as a speaker for RAPS, Medical Alley and AMWA.

Stefanie Martinez Koenig | Director of Clinical & Regulatory Affairs

Stefanie Martinez Koenig is a key member of the Bannick Executive Team. As the Director of Clinical and Regulatory Affairs, she is tasked with providing overall program leadership and management of our regulatory affairs, including medical writing, and clinical affairs groups. She looks forward to partnering closely with clients to identify their needs, resolve any issues and ensure on time service delivery.

Stefanie is a results-driven executive with more than 25 years of experience working in quality assurance and regulatory affairs for the device, pharmaceutical, and biopharma sectors. She is a strategic change-agent with proven accomplishments and has been recognized for developing creative and extraordinary partnerships to meet business objectives. She brings to the Bannick team strong experience in quality systems and auditing, MDD to MDR transition, regulatory and clinical affairs.

Stefanie has a BS in Microbiology and MS in Operations and Technology Management. She is an active member of RAPS, an ASQ Certified Quality Engineer (CQE), and a Certified Quality Manager in Operational Excellence.

Stefanie Martinez Koenig

Jim Webb | Director of Operations & Quality Systems

Jim Web

James (Jim) Webb is a key member of the Bannick executive team. Since coming aboard as the Director of Operations and Quality Systems, he has provided overall program leadership and management to the organization in the critical areas of Human Resources, Business Development, Information Technology, Quality, and Operations. He is a key point of escalation in the resolution of issues. 

Jim is an executive who has worn a lot of hats in his career, amassing over 30 years of progressive experience in the consulting, medical device, retail, and distribution sectors. He is passionate about improvement and attaining the unachievable through collaboration, analysis, and persistence. He brings to the Bannick team this passion and tenacity, having driven numerous process improvements within the company, including the Bannick Quality System. 

When he isn’t working, Jim enjoys playing darts, playing bean bags, and spending time with his wife and their Zuchon, Dalton.

RAPS Logo
AMWA Logo
Medical Alley Logo
Minneapolis and St. Paull Business Journal Logo

We are your subject matter experts!

We're Here To Help!

9 + 15 =

Bannick Primary requires contact information to provide you with detail about our services. You may unsubscribe at any time. For information on how to unsubscribe as well as our privacy practices and commitment to protecting your privacy, please read our privacy statement.