Device History Record (DHR)

A Device History Record (DHR) is a comprehensive documentation that captures the complete history of a medical device’s production, including design, manufacturing processes, quality control measures, and compliance with regulatory standards. It serves as a critical tool for ensuring traceability, accountability, and adherence to industry regulations throughout the Produktlebenszyklus. By maintaining a detailed DHR, organizations can facilitate effective audits, enhance product safety, and support continuous improvement in product design and manufacturing practices.