This project involved a comprehensive assessment and harmonization of the Design History File (DHF) for a blood separation device, falling under sustaining engineering for a medical product line. The approach included a thorough review of the existing DHF, encompassing requirements, verification, validation, regulatory compliance, and risk management files. During this review, the team identified critical…
In a critical engagement for a medical product line, ALTEN Technology successfully undertook the assessment and harmonization of the Design History File (DHF) for a blood separation device. Their comprehensive approach involved meticulously reviewing the existing DHF to identify gaps in system and software requirements, verification, and documentation, as well as addressing nonconformances identified by a notified body. This rigorous effort culminated in the complete organization of the DHF, harmonization of traceability and design verification data, and the closure of all identified remediation gaps, ultimately ensuring regulatory compliance, including the delivery of an IEC 62304 compliance report.