In-house developed processes and procedures which use common computer software such as those found in Microsoft Office(Word, Excel, etc.) may in many situations be considered a Blood Establishment Computer System (BECS) or a component of a Medical Device Data System. This session will define a Medical Device Data System (MDDS) and describe how it applies to blood centers, transfusion services, and other allied services (such as bone or tissue or cell therapy). The presenters will also explain how to apply quality system requirements found in 21CRF Part 820. In addition, successful methods and strategies to help participants identify if a MDDS is in use at their facility will be provided, as well as requirements and methods for achieving regulatory compliance for these applications.