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Início └ISO 13485:2016 Medical Devices QMS Essentials
ISO 13485:2016 Medical Devices QMS Essentials

ISO 13485:2016 Medical Devices QMS Essentials

This course is for quality managers, regulatory affairs professionals, and internal auditors working in medical device organizations. Participants will be able to interpret ISO 13485:2016, apply its risk-based and regulatory requirements, evaluate key quality processes, and prepare their organization for certification audits.

5000,00 LE
5000.0 EGP 5000,00 LE
5000,00 LE
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Responsável Rehaf Foula
Última Atualização 18/10/2026
Membros 1
Health
  • 1. Standard Orientation
    1Aulas ·
    • 1.1 Welcome
      Novo
  • 2. Structure and Context
    2Aulas ·
    • 2.1 Purpose and Applicability
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    • 2.2 Clause Architecture
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  • 3. Risk and Regulation
    5Aulas ·
    • 3.1 Risk-Based Foundations
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    • 3.2 Risk Management Interfaces
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    • 3.3 Regulatory Responsibilities
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    • 3.4 Market and Jurisdiction Controls
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    • 3.5 Records and Evidence
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  • 4. Design and Development
    6Aulas ·
    • 4.1 Design Planning Controls
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    • 4.2 Design Inputs and Outputs
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    • 4.3 Design Review Discipline
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    • 4.4 Verification and Validation
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    • 4.6 Design Records and Files
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    • 4.7 Design Control Assessment
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  • 5. Supplier and Purchasing Controls
    3Aulas ·
    • 5.1 Supplier Classification
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    • 5.2 Purchasing Information
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    • 5.3 Supplier Control Plan
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  • 6. Production and Special Processes
    7Aulas ·
    • 6.1 Production Planning
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    • 6.2 Work Environment Controls
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    • 6.3 Device Identification and Traceability
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    • 6.4 Property and Preservation
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    • 6.6 Sterile Device Controls
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    • 6.7 Implantable Device Controls
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    • 6.8 Production Readiness Review
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  • 7. CAPA and Improvement
    4Aulas ·
    • 7.1 Nonconformity Response
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    • 7.2 Root Cause Analysis
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    • 7.3 Corrective and Preventive Action
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    • 7.4 Effectiveness and Escalation
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  • 8. Internal Audit Program
    4Aulas ·
    • 8.1 Audit Program Design
      Novo
    • 8.2 Audit Planning and Sampling
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    • 8.3 Interviewing and Evidence
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    • 8.5 Internal Audit Simulation
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  • 9. Certification Readiness
    3Aulas ·
    • 9.1 Certification Pathway
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    • 9.2 Readiness and Gap Analysis
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    • 9.3 Management Review Evidence
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  • 10. Integrated Application
    1Aulas ·
    • 10.1 Key Takeaways
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