Kimberly McCoy - Senior Consultant, Quality Assurance & Regulatory

As a Senior Consultant for QA and RA, Kimberly has diverse responsibilities. She is actively involved in helping Emergo clients with varied issues including device assessment, classification, labeling reviewing, and analysis of regulatory documentation.

In her years of experience with notable device manufacturers such as Ethicon Endo-Surgery, Johnson & Johnson, Genzyme Biosurgery and Encore Medical, she frequently performed regulatory analyses for devices, compiled Technical Files and Design Dossiers and prepared FDA 510(k), IDE and PMA submissions. Her knowledge of regulatory issues is supplemented by her experience with quality assurance issues related to ISO 13485:2003 and FDA GMP. She puts this extensive knowledge to work for the benefit of Emergo clients worldwide.