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.
Wednesday, October 28, 2020
13:30 – 14:30 CET