[The Traceability Management for Qualification Documents of Medical Instruments]

Area of Science:

• Medical device management
• Information systems in healthcare

Background:

• Effective management of medical instrument qualification documents is crucial for regulatory compliance and operational efficiency.
• The large volume and time-sensitive nature of these documents present significant logistical challenges for management departments.

Purpose of the Study:

• To address the difficulties in managing medical instrument qualification documents.
• To develop and evaluate an information management system designed to streamline document control and enhance traceability.

Main Methods:

• Development of a novel information management system incorporating traceability functions.
• Implementation of standardized procedures for handling medical instrument qualification documents within the system.

Main Results:

• The developed system successfully standardizes the management of qualification documents.
• The system ensures that qualification documents are readily available and traceable.
• A reduction in the overall workload associated with medical instrument management was observed.

Conclusions:

• The implemented information management system effectively overcomes the challenges of managing medical instrument qualification documents.
• Traceability and accessibility of critical documents are significantly improved, leading to more efficient medical device management.