Regulatory modernization has established the Total Product Lifecycle (TPLC) as the central framework for medical device oversight, extending regulatory accountability beyond manufacturers to healthcare delivery organizations. Within hospitals, clinical engineering and health technology management departments control device acceptance, configuration, maintenance, incident response, and recall execution, positioning them as primary generators of real-world reliability evidence. Global regulators—including the U.S. Food and Drug Administration (FDA), the European Union under MDR/IVDR, and multijurisdictional audit programs such as MDSAP—now require continuous, traceable demonstration of device safety and performance across all lifecycle phases. This paper examines the regulatory logic driving this shift and demonstrates how reliability engineering operationalizes TPLC requirements through interspersed clinical engineering activities that span procurement, operations, and post-market vigilance. A comparative review of international regulatory approaches, together with a lifecycle crosswalk and a healthcare delivery–centered TPLC map, illustrates how routine activities such as acceptance testing, maintenance, CAPA, and recall management function as integrated quality system controls, collectively substantiating device reliability throughout real-world use.
Beth Ann Fiedler (Wed,) studied this question.