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Medical Device Consulting Firm
20+years medical device industry experience
hands on preparation of PMA, 510(k) and IDE submissions
monitoring and clinical management experience
regulatory strategy development and execution
excellent writing skills
Full Spectrum of services--from product development thru to market release
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For over 20 years, Ms. Bannick has worked with device companies to bring Class II and III products to market in the US and abroad. She has a BA in statistics and computer science, a Master’s in Health and Human Services Administration, and a Master’s in Management. Bannick Consulting provides strategic clinical and regulatory guidance to medical companies, bringing teams to FDA to negotiate submission strategy, and preparing the clinical protocols and regulatory documents to apply those strategies. Ms. Bannick brings a broad base of expertise to each project. 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 completed projects in many fields, including cardiovascular, neurological, urological, chronic pain, and sleep apnea. She is a speaker for RAPS, Life Science Alley, Clinical Device Group, AMWA, and Thomsen.
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| 3701 Munkelwitz Rd., Isle, MN 56342 office: 320-676-1440 fax: 320-676-1444 cell: 320-630-5171 Contact Karen at karen@bannickconsulting.com
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