Glossary

Medical Device Quality Management System

Medical Device Quality Management System

A device history record quality management system is a fundamental component of the broader medical device QMS. It specifically manages the creation, control, maintenance, and disposition of device history records (DHRs). These records document a medical device's entire life cycle, from design and manufacture to distribution and use. An effective QMS ensures complete, accurate, and retrievable DHRs, which are critical for regulatory compliance, traceability (allowing you to track a device's production history), and postmarket surveillance of device performance. By effectively managing these records, a QMS contributes to the overall quality and safety of medical devices. 

Frequently Asked Questions

What are the key components of a medical device QMS?

The key components of a medical device QMS typically include document control, management responsibility, resource management, product realization, measurement, analysis, improvement, risk management, clinical evaluation, postmarket surveillance, and regulatory compliance processes.

Which International standards is commonly used for medical device QMS?

ISO 13485 is the most commonly used international standard for evaluating the effectiveness of a medical device QMS. The ISO 13485 standard specifies the requirements an organization’s QMS must fulfil to demonstrate that medical devices and related services can consistently meet customer expectations and applicable regulatory requirements.

What is risk management in the context of a medical device QMS?

Risk management in relation to a medical device QMS refers to the systematic application of policies, procedures, and practices involved in the tasks of analyzing, evaluating, controlling, mitigating, and monitoring risk. It is a continuous process throughout the life cycle of the device to ensure that the safety and performance of the device are maintained.

What is the role of management in the context of a medical device QMS?

Management plays a critical role in overseeing a medical device QMS. They are responsible for demonstrating leadership and commitment to the QMS by ensuring the availability of necessary resources, establishing quality objectives, conducting management reviews, ensuring customer focus, and fostering a culture of quality and continuous improvement within the organization.

How is continuous improvement achieved in a QMS?

Continuous improvement in a QMS is achieved by conducting quality audits, data analysis, corrective actions/preventive actions (CAPAs), management reviews, and customer feedback assessments. These activities are helpful for identifying areas of improvement and implement actions that can enhance the quality management system's effectiveness and efficiency.

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