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MasterControl eTMF Manager for Medical Device

MasterControl eTMF Manager for Medical Device

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About This Document

The management of a trial master file (TMF) for a clinical study conducted for medical device products goes beyond simply managing the creation, review, and approval of content that is generated throughout a clinical study. Each clinical study must meet good clinical practice (GCP) regulatory standards for execution, such as ICH E6 and ICH E8 (which delineate the responsibilities and expectations of all participants in clinical studies), as well as the ISO 14155 standard for design, conduct, recording, and reporting of clinical investigations carried out in human subjects.