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
| Responsable | Rehaf Foula |
|---|---|
| Última actualización | 18/10/2026 |
| Miembros | 1 |
Health
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1. Standard Orientation1Lecciones ·
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1.1 WelcomeNuevo
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2. Structure and Context2Lecciones ·
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2.1 Purpose and ApplicabilityNuevo
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2.2 Clause ArchitectureNuevo
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3. Risk and Regulation5Lecciones ·
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3.1 Risk-Based FoundationsNuevo
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3.2 Risk Management InterfacesNuevo
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3.3 Regulatory ResponsibilitiesNuevo
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3.4 Market and Jurisdiction ControlsNuevo
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3.5 Records and EvidenceNuevo
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4. Design and Development6Lecciones ·
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4.1 Design Planning ControlsNuevo
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4.2 Design Inputs and OutputsNuevo
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4.3 Design Review DisciplineNuevo
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4.4 Verification and ValidationNuevo
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4.6 Design Records and FilesNuevo
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4.7 Design Control AssessmentNuevo
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5. Supplier and Purchasing Controls3Lecciones ·
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5.1 Supplier ClassificationNuevo
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5.2 Purchasing InformationNuevo
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5.3 Supplier Control PlanNuevo
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6. Production and Special Processes7Lecciones ·
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6.1 Production PlanningNuevo
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6.2 Work Environment ControlsNuevo
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6.3 Device Identification and TraceabilityNuevo
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6.4 Property and PreservationNuevo
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6.6 Sterile Device ControlsNuevo
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6.7 Implantable Device ControlsNuevo
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6.8 Production Readiness ReviewNuevo
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7. CAPA and Improvement4Lecciones ·
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7.1 Nonconformity ResponseNuevo
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7.2 Root Cause AnalysisNuevo
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7.3 Corrective and Preventive ActionNuevo
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7.4 Effectiveness and EscalationNuevo
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8. Internal Audit Program4Lecciones ·
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8.1 Audit Program DesignNuevo
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8.2 Audit Planning and SamplingNuevo
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8.3 Interviewing and EvidenceNuevo
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8.5 Internal Audit SimulationNuevo
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9. Certification Readiness3Lecciones ·
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9.1 Certification PathwayNuevo
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9.2 Readiness and Gap AnalysisNuevo
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9.3 Management Review EvidenceNuevo
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10. Integrated Application1Lecciones ·
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10.1 Key TakeawaysNuevo
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