Course Overview:
This course provides comprehensive guidance on establishing and managing an effective quality assurance program for medical devices. Its aim is to enhance participants’ understanding of the importance of quality assurance in the healthcare sector and equip them with the knowledge and skills necessary to ensure the safety and efficiency of medical devices.
Course Objectives:
- Introduce participants to the significance of quality assurance and its impact on patient safety and performance efficiency.
- Design and implement comprehensive quality assurance programs for medical devices, including necessary policies and procedures.
- Develop skills for inspecting and performing preventive maintenance on devices to ensure ongoing performance.
- Apply safety evaluation procedures and performance testing to ensure compliance with required standards.
- Manage the lifecycle of medical equipment from acquisition to final disposal.
- Enhance procedures for improving patient safety when using medical devices.
- Prepare detailed reports reflecting the performance and maintenance history of devices within the quality assurance program.
Training Content:
- Importance of Quality Assurance: Understanding the impact of quality assurance on patient safety and medical device efficiency.
- Designing and Implementing Programs: Developing necessary policies and procedures for ensuring device quality.
- Principles and Electrical Safety Testing: Key principles of quality assurance and their application.
- Device Inspection and Maintenance: Techniques for preventive maintenance to ensure device efficiency.
- Safety Evaluation Procedures: Applying necessary tests to ensure devices meet established standards.
- Lifecycle Management: Managing assets from acquisition to disposal to ensure sustainability.
- Improving Patient Safety: Developing procedures for analyzing and mitigating risks associated with medical devices.
- Reporting: Preparing performance and maintenance reports and utilizing data management systems to support quality assurance.
- Regulatory Standards: Understanding laws and standards related to medical device quality.
Target Audience:
This course is designed for professionals in the healthcare field, including biomedical engineers, technicians, quality managers, and individuals working in maintenance and quality control departments in hospitals and medical centers.
