Clinical Evaluation Reports and manuscript development
Clinical protocol design, statistical planning and study analysis
Regulatory strategy development and submissions, including q-sub submissions and FDA meetings
Preparation of PMA, 510(k) and IDE submissions in the US and Design Dossiers and Technical Files in the European Community
Quality Systems: gap analysis of 13485 to 2016, development and enhancement of quality systems
Reimbursement strategy development
Bannick Consulting Alliance is a network of subject matter experts ready to tackle any aspect of medical device product development, including advising development teams on strategy, clinical study design, reimbursement strategy and market approval in the US and EU. Each of our experts has demonstrated ability to provide strategic clinical, quality, 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." We are passionately engaged in this industry and thrive on our contribution to the health and safety of patients around the world.
President and Founder: Karen Bannick
For over 25 years, Ms. Bannick has worked with device companies to bring Class II and III products to market in the US and internationally.
Ms. Bannick brings a broad base of expertise to each project, working with clinical and regulatory and medical writing groups alike. She has prepared PMAs, IDEs, and 510(k)s; clinical protocols, data collection forms and data managements systems; and manuscripts, white papers and statistical analysis reports. She has prepared over 70 clinical evaluation reports per MedDev 2.7.1. She has completed projects in many fields, including cardiovascular, neurological, pain management, wound care, urological, chronic pain, and sleep apnea.
She has a BA in biostatistics, MA in Health and Human Services Administration, and an MA in management. She 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.