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