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