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Health And Safety

ISO 13485:2016 Medical Device QMS Course | OilTrain

International Organization For Standardization ISO

Institute: International Organization For Standardization ISO

Certificate Type: International Certificate

Courses Descriptions

Learn medical device validation, CAPA systems, and audit readiness based on ISO 13485:2016 with OilTrain. Protect your production compliance.

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
0:00:00
Management Review and Continuous Improvement
0:00:00

Design and Development Planning and Control
0:00:00
Design Inputs, Outputs, Review, and Validation
0:00:00
Supplier Management and Purchasing Controls
0:00:00
Production and Service Provision
0:00:00
Sterility, Cleanliness, and Contamination Control
0:00:00
Process Validation and Traceability
0:00:00

Control of Nonconforming Products
0:00:00
Internal Audits: Planning and Execution
0:00:00
Monitoring and Measuring Processes and Products
0:00:00
Customer Feedback and Complaint Handling
0:00:00
Post-Market Surveillance
0:00:00
Corrective and Preventive Actions (CAPA)
0:00:00

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
0:00:00
Roles and Responsibilities in QMS Implementation
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Maintaining Compliance and Continuous Improvement
0:00:00
Course Wrap-Up and Final Assessment
0:00:00

Institution

International Organization For Standardization ISO
International Organization For Standardization ISO

ISO develops globally accepted standards. An ISO certification strengthens your CV, proves global best-practice knowledge, and improves career opportunities worldwide.

Certificate Type: International Certificate

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Courses Includes:

  • Price : ₦420,000.00
  • Institute : International Organization For Standardization ISO
  • Durations : 38 Hour
  • Lessons : 32
  • Students : 0
  • Language : English
  • Level : Expert Level
  • Certifications : Yes
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