设计历史档案 (DHF)

A Design History File (DHF) is a comprehensive collection of documents and records that detail the design and development process of a medical device or product, ensuring compliance with regulatory standards. It encompasses all design inputs, outputs, 验证 和 验证 activities, and changes made throughout the product lifecycle. The DHF serves as a critical reference for maintaining quality assurance and facilitating audits, thereby demonstrating that the product meets both user needs and regulatory requirements.