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Glen Emelock has over three decades of experience in the medical device and clinical trial sectors. Currently serving as Contract Lead Auditor and Technical Expert at the National Standards Authority of Ireland since 2003, Glen focuses on ISO 13485, EUMDD, EUIVDD, and CMDCAS assessments. As a Senior Partner at The CRO Group, Inc. since 1996, responsibilities include managing FDA-required consumer and OTC clinical trials, preparing 510(k) submissions, and establishing compliance with ISO 13485 and risk management processes. Previous roles include Director of the Medical Device Division at both TUV Product Service and TUV America, where Glen oversaw ISO assessments, and Hardware & Software Development Manager at Millipore, concentrating on drug device combination systems.