Debbie Richards is a labeling and useability specialist, helping companies ensure that labels comply with FDA’s Unique Device Identifier (UDI) regulations and the various regulations for OUS markets. Her roles include setting up a label creation process, selecting label creation software, choosing the appropriate UDI issuing agency, registering with the FDA GUDID, writing labeling requirements and SOPs, developing labeling artwork and writing IFU’s. She also helps in-house teams accomplish labeling tasks by creating guidance documents, SOPs, and conducting training and testing. She’s created US and EU labeling and user manuals for implantable medical device systems used in clinical studies. Ms. Richards conducts Human Factors and usability testing in support of IDE, HDE and PMA submissions, and has authored an original, first in man, IDE for an implantable EMG sensor system which was conditionally approved during the first round of regulatory review.