Courses Descriptions
"Learn about ISO 13485:2016, the quality management system standard for ensuring safety and effectiveness in medical device manufacturing."
Overview of ISO 13485:2016
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Importance of QMS in the Medical Device Industry
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Scope and Applicability of the Standard
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Key Terms and Definitions
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Differences between ISO 13485 and ISO 9001
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Regulatory Context and Global Acceptance
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Benefits of Implementing ISO 13485
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Leadership and Top Management Responsibilities
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Quality Policy and Strategic Planning
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Risk-Based Thinking and Risk Management in QMS
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Quality Objectives and Performance Monitoring
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Documentation Requirements and Quality Manual
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Management Review and Continuous Improvement
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Design and Development Planning and Control
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Design Inputs, Outputs, Review, and Validation
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Supplier Management and Purchasing Controls
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Production and Service Provision
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Sterility, Cleanliness, and Contamination Control
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Process Validation and Traceability
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Control of Nonconforming Products
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Internal Audits: Planning and Execution
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Monitoring and Measuring Processes and Products
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Customer Feedback and Complaint Handling
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Corrective and Preventive Actions (CAPA)
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Steps to Achieve ISO 13485 Certification
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Preparing for Certification Audits
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Common Nonconformities and How to Avoid Them
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Roles and Responsibilities in QMS Implementation
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Maintaining Compliance and Continuous Improvement
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Course Wrap-Up and Final Assessment
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