Quality Management System for Medical Devices-ISO 13485
Learn all the sections and subsections of the ISO13485 QMS standard for the expert!
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6
students
2 hours
content
Aug 2024
last update
$19.99
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Why take this course?
π Course Title: Quality Management System for Medical Devices - ISO 13485 π Master the Art of Quality in the Medical Device Industry
π Course Instructor: Anil Sharma Kandel
π₯ Key Learning Outcomes:
- π Understand the Structure: Unravel the hierarchical layout of ISO 13485:2016, from its high-level structure to its specific requirements.
- π± Adopt a Risk-Based Approach: Learn how to seamlessly integrate risk management into your QMS.
- π Essential Documentation: Master the creation and maintenance of the Quality Manual, Medical Device Files, and other essential documentation.
- π§© Management Involvement: Explore the critical role of management in overseeing the quality system and fostering an organizational commitment to quality excellence.
- π Resource Management: Acquire insights into effective utilization of resources, including human capital, infrastructure, and working environment.
- π§ Product Realization Lifecycle: Gain a comprehensive understanding of the stages from design, development, manufacturing, to post-market surveillance.
- π Improvement Tools: Discover key tools for monitoring performance, conducting root cause analysis, and implementing corrective and preventive actions.
β« By completing this course, you will:
- π§ Navigate ISO 13485 with Confidence: Acquire a thorough understanding of the standard's requirements.
- π οΈ Apply ISO Principles Practically: Implement ISO 13485 principles within your organization to enhance quality management processes.
- π Build and Maintain an Effective QMS: Use your newly acquired knowledge to contribute significantly to your organization's quality system.
- π Impact Medical Device Safety & Efficacy: Strengthen your comprehension of how a robust QMS directly affects the safety and efficacy of medical devices.
Embark on your path to becoming an ISO 13485 expert today! Enroll in our Mastering ISO 13485:2016 course and elevate your career by becoming a key player in the quality management landscape of the medical device industry. π©ββοΈππ«
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6121495
udemy ID
11/08/2024
course created date
22/10/2024
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