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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.

5 000,00 LE
5000.0 EGP 5 000,00 LE
5 000,00 LE
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Responsable Rehaf Foula
Dernière mise à jour 18/10/2026
Membres 1
Health
  • 1. Standard Orientation
    1Leçons ·
    • 1.1 Welcome
      Nouveau
  • 2. Structure and Context
    2Leçons ·
    • 2.1 Purpose and Applicability
      Nouveau
    • 2.2 Clause Architecture
      Nouveau
  • 3. Risk and Regulation
    5Leçons ·
    • 3.1 Risk-Based Foundations
      Nouveau
    • 3.2 Risk Management Interfaces
      Nouveau
    • 3.3 Regulatory Responsibilities
      Nouveau
    • 3.4 Market and Jurisdiction Controls
      Nouveau
    • 3.5 Records and Evidence
      Nouveau
  • 4. Design and Development
    6Leçons ·
    • 4.1 Design Planning Controls
      Nouveau
    • 4.2 Design Inputs and Outputs
      Nouveau
    • 4.3 Design Review Discipline
      Nouveau
    • 4.4 Verification and Validation
      Nouveau
    • 4.6 Design Records and Files
      Nouveau
    • 4.7 Design Control Assessment
      Nouveau
  • 5. Supplier and Purchasing Controls
    3Leçons ·
    • 5.1 Supplier Classification
      Nouveau
    • 5.2 Purchasing Information
      Nouveau
    • 5.3 Supplier Control Plan
      Nouveau
  • 6. Production and Special Processes
    7Leçons ·
    • 6.1 Production Planning
      Nouveau
    • 6.2 Work Environment Controls
      Nouveau
    • 6.3 Device Identification and Traceability
      Nouveau
    • 6.4 Property and Preservation
      Nouveau
    • 6.6 Sterile Device Controls
      Nouveau
    • 6.7 Implantable Device Controls
      Nouveau
    • 6.8 Production Readiness Review
      Nouveau
  • 7. CAPA and Improvement
    4Leçons ·
    • 7.1 Nonconformity Response
      Nouveau
    • 7.2 Root Cause Analysis
      Nouveau
    • 7.3 Corrective and Preventive Action
      Nouveau
    • 7.4 Effectiveness and Escalation
      Nouveau
  • 8. Internal Audit Program
    4Leçons ·
    • 8.1 Audit Program Design
      Nouveau
    • 8.2 Audit Planning and Sampling
      Nouveau
    • 8.3 Interviewing and Evidence
      Nouveau
    • 8.5 Internal Audit Simulation
      Nouveau
  • 9. Certification Readiness
    3Leçons ·
    • 9.1 Certification Pathway
      Nouveau
    • 9.2 Readiness and Gap Analysis
      Nouveau
    • 9.3 Management Review Evidence
      Nouveau
  • 10. Integrated Application
    1Leçons ·
    • 10.1 Key Takeaways
      Nouveau