A few days ago, the “Provisions on the Supervision and Management of Enterprises’ Implementation of the Main Responsibility of Medical Device Quality and Safety” formulated and issued by the State Food and Drug Administration has been officially implemented on March 1. We learned from the latest Measures for the Supervision and Management of Medical Devices that the quality management of enterprises operating the third type of medical devices has become increasingly strict, and clearly put forward the need to equip a computer information management system that conforms to the quality management of medical device operation. In the face of increasingly strict quality supervision of medical devices, all kinds of medical device manufacturing and operating enterprises are not careless. The light is to face punishment, and the heavy is to lay hidden dangers for medical safety accidents, affecting enterprise reputation and business continuity. So, what are the medical equipment quality registration management system and medical equipment quality traceability management system commonly used by many medical devices nowadays? What is the relationship between the two, and can their existence meet the requirements of medical device enterprises for medical device quality control in the new era?
In this issue, medical device digital management experts talk with you about this topic: the relationship between the medical device quality traceability management system and the medical device quality registration management system.
◆ Medical equipment quality traceability management system refers to the establishment of a complete data record and information interaction system to track and record the whole process of medical equipment from production, sales, use to scrap, so as to achieve effective traceability and supervision of medical equipment quality. This can improve the quality and safety level of medical equipment and ensure the safety of patients’ medication.
◆ The medical equipment quality registration management system refers to the registration, management and maintenance of all medical equipment used in the hospital through the establishment of the medical equipment information database, including the equipment model, specification, manufacturer, import/domestic, procurement time, user department, maintenance records and other information, so as to facilitate the comprehensive management and monitoring of the use and maintenance of medical equipment and ensure the safe and effective use of the equipment.
From the perspective of medical equipment quality management, both medical equipment quality traceability management system and medical equipment quality registration management system are important system tools for medical equipment quality management.
✔ The medical equipment quality registration management system provides basic information for the management and maintenance of medical equipment in a hierarchical manner;
✔ The medical equipment quality traceability management system realizes the traceability and supervision of the medical equipment quality through these key information collected by the medical equipment quality registration management system.
To be precise, they are the colleague relationship between the former and the latter in the medical equipment quality management workshop. The existence and close cooperation of the two systems can improve the efficiency and quality of medical equipment management for medical institutions and ensure the safety of patients’ medication.
If we have to distinguish between the medical equipment quality traceability management system and the medical equipment quality registration management system, it is really difficult and absolutely unnecessary! Because of the lack of information collection of the medical equipment quality registration management system, the medical equipment quality traceability management system lacks an important reference basis for quality traceability and supervision, both of which are indispensable.
For medical equipment quality traceability management system and medical equipment quality registration management system, we may choose one of them to explore the modern management. With the impact of the second digital wave, the quality traceability management system of digital medical equipment has become the standard configuration of more and more leading medical device companies.
Through the solution of the digital medical equipment quality traceability management system brought by SAP below for the medical equipment quality traceability management, we use the cloud system to build a complete product quality traceability system to realize the whole process, transparent real-time cloud traceability management from purchase warehousing to sales delivery.
Of course, for medical device manufacturing enterprises, SAP medical device quality traceability management system will bring different solutions. Through ERP, WMS and PLM, the whole life cycle management and traceability of medical device products are carried out to ensure the traceability of product quality.
In summary, through the above analysis and comparison, we can see that in the quality management of medical equipment, the existence of the medical equipment quality traceability management system and the medical equipment quality registration management system are inseparable, and they complement each other. Of course, with the popularity of the digital medical equipment quality traceability management system and the medical equipment quality registration management system, more and more medical device companies have built standardized, simplified and unified information platforms, integrated sales channels, enterprise operations and customer relationships, realized efficient operation of enterprises, accelerated business development and transformation, and maintained industry advantages.
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This article "What is the relationship between the medical equipment quality traceability management system and the medical equipment quality registration management system?" by AcloudEAR. We focus on business applications such as cloud ERP.
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