Beth LoringJun 27, 20232 minFDA Guidance on the Q-Submission ProgramCheck out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!
Beth LoringApr 7, 20232 minFYI, Most Medical Devices Are Not Designed For Most PeopleRead about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.
Beth LoringDec 14, 20214 minSummary of MedTech Intelligence’s Webinar from Nov 30th, 2021I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...
Beth LoringSep 21, 20213 minFDA Final Rule on the Use of Symbols in LabelingIntroduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...