Keywords
Design and development documents
Quality system
Submitted : 2025-08-06
Accepted : 2025-08-21
Published : 2025-09-05
Abstract
This paper highlights the critical role of medical device design and development documents within the quality system, including their compliance with regulatory standards, their function as a traceable record, their support for all stages, and their use in risk and change management. It also covers document template creation, review record association, information management, adverse event traceability, and the reconciliation of differences in international declarations.
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