your parnter in medical device product development

Your strategic partner for development and implementation of US and EU clinical and regulatory affairs, including CERs and PMCF

Bannick, LLC – a primary device group

Call for Consultation

Don’t Settle For Less

Optimize Your Goals and Objectives

  • Regulatory strategy development and submissions preparation.
    -Preparation of PMA, 510(k) and IDE submissions in the US and Technical Documents in the European Community.
  • Clinical Evaluation Plans and Reports.
  • PMCF Plans and Reports.
  • Clinical protocol design, statistical planning and study analysis.
  • Quality Systems: gap analysis of 13485 to 2016, development and enhancement of quality systems.

Charge Forward

Strategies Built Exactly To Your Needs

Our team of experts at Bannick Primary can develop your regulatory strategy, clinical study design and clinical evaluation for the US, EU and beyond. 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.” We are passionately engaged in this industry and thrive on our contribution to the health and safety of patients around the world.

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Our Specialties

We Can Do It All. Get In Touch For a Free Consultation

 

Regulatory strategy development and submissions preparation.

Preparation of PMA, 510(k) and IDE submissions in the US and technical documents in the European Community.

Clinical Evaluation Plans and Reports.

PMCF Plans and reports.

Clinical protocol design, statistical planning and study analysis.

Quality Systems: gap analysis of 13485 to 2016, development and enhancement of quality systems.

Services

What We Can Do For You

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CLINICAL AFFAIRS

Clinical study design: premarket, safety, efficacy, postmarket.

Literature search and summary.

Clinical Evaluation: plans and reports (MDR readiness, gap assessment and implementation).

PMCF: plans and reports.

Protocol and CRF development.

Clinical study management: ivestigator meetings, site training and monitoring.

Statistical Analysis

REGULATORY AFFAIRS

Development and execution of domestic & international regulatory strategies.

Preparation of US (PMAs, IDEs, and 510(k)s) and EU MDR technical documents.

QUALITY SYSTEMS

Establish and maintain Quality Systems compliant with FDA QSR and ISO 13485:2016.

Create and implement Quality System procedures: documentation control, design control, CAPA, complaint handling, management review, purchasing, receiving, calibration, internal and external auditing, and inspection.

Quality Auditing: internal (FDA QSR and ISO 13485:2016), supplier, ISO 13485:2016 and MDSAP GAP assessment.

ISO 13485:2016 transition.

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MEDICAL WRITING

Preparation of clinical evaluation reports (CERs), manuscripts, clinical study reports, regulatory submissions and annual reports for many topic areas, including: cardiology, neurology, urology, brain stimulation, neurostimulation, and urinary incontinence.

We pride ourselves on our ability to critically assess your clinical evidence. We prepare analysis & summarization of results. We are skilled at report & table generation for many types of documents–both internal reports and external publications, including FDA submissions, abstracts for specialty congresses and marketing pieces as well as technical manuals & labeling.

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

About Our President & Founder

Karen Bannick

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.

Get In Touch

+1 305-707-7610
info@bannickprimary.com
Offices in FL and MN