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Home └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.

5.000,00 LE
5000.0 EGP 5.000,00 LE
5.000,00 LE
In den Warenkorb
Verantwortlich Rehaf Foula
Letzte Aktualisierung 18.10.2026
Mitglieder 1
Health
  • 1. Standard Orientation
    1Lektionen ·
    • 1.1 Welcome
      Neu
  • 2. Structure and Context
    2Lektionen ·
    • 2.1 Purpose and Applicability
      Neu
    • 2.2 Clause Architecture
      Neu
  • 3. Risk and Regulation
    5Lektionen ·
    • 3.1 Risk-Based Foundations
      Neu
    • 3.2 Risk Management Interfaces
      Neu
    • 3.3 Regulatory Responsibilities
      Neu
    • 3.4 Market and Jurisdiction Controls
      Neu
    • 3.5 Records and Evidence
      Neu
  • 4. Design and Development
    6Lektionen ·
    • 4.1 Design Planning Controls
      Neu
    • 4.2 Design Inputs and Outputs
      Neu
    • 4.3 Design Review Discipline
      Neu
    • 4.4 Verification and Validation
      Neu
    • 4.6 Design Records and Files
      Neu
    • 4.7 Design Control Assessment
      Neu
  • 5. Supplier and Purchasing Controls
    3Lektionen ·
    • 5.1 Supplier Classification
      Neu
    • 5.2 Purchasing Information
      Neu
    • 5.3 Supplier Control Plan
      Neu
  • 6. Production and Special Processes
    7Lektionen ·
    • 6.1 Production Planning
      Neu
    • 6.2 Work Environment Controls
      Neu
    • 6.3 Device Identification and Traceability
      Neu
    • 6.4 Property and Preservation
      Neu
    • 6.6 Sterile Device Controls
      Neu
    • 6.7 Implantable Device Controls
      Neu
    • 6.8 Production Readiness Review
      Neu
  • 7. CAPA and Improvement
    4Lektionen ·
    • 7.1 Nonconformity Response
      Neu
    • 7.2 Root Cause Analysis
      Neu
    • 7.3 Corrective and Preventive Action
      Neu
    • 7.4 Effectiveness and Escalation
      Neu
  • 8. Internal Audit Program
    4Lektionen ·
    • 8.1 Audit Program Design
      Neu
    • 8.2 Audit Planning and Sampling
      Neu
    • 8.3 Interviewing and Evidence
      Neu
    • 8.5 Internal Audit Simulation
      Neu
  • 9. Certification Readiness
    3Lektionen ·
    • 9.1 Certification Pathway
      Neu
    • 9.2 Readiness and Gap Analysis
      Neu
    • 9.3 Management Review Evidence
      Neu
  • 10. Integrated Application
    1Lektionen ·
    • 10.1 Key Takeaways
      Neu