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
| Responsabile | Rehaf Foula |
|---|---|
| Ultimo aggiornamento | 18/10/2026 |
| Iscritti | 1 |
Health
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1. Standard Orientation1Lezioni ·
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1.1 WelcomeNuovo
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2. Structure and Context2Lezioni ·
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2.1 Purpose and ApplicabilityNuovo
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2.2 Clause ArchitectureNuovo
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3. Risk and Regulation5Lezioni ·
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3.1 Risk-Based FoundationsNuovo
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3.2 Risk Management InterfacesNuovo
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3.3 Regulatory ResponsibilitiesNuovo
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3.4 Market and Jurisdiction ControlsNuovo
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3.5 Records and EvidenceNuovo
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4. Design and Development6Lezioni ·
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4.1 Design Planning ControlsNuovo
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4.2 Design Inputs and OutputsNuovo
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4.3 Design Review DisciplineNuovo
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4.4 Verification and ValidationNuovo
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4.6 Design Records and FilesNuovo
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4.7 Design Control AssessmentNuovo
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5. Supplier and Purchasing Controls3Lezioni ·
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5.1 Supplier ClassificationNuovo
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5.2 Purchasing InformationNuovo
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5.3 Supplier Control PlanNuovo
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6. Production and Special Processes7Lezioni ·
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6.1 Production PlanningNuovo
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6.2 Work Environment ControlsNuovo
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6.3 Device Identification and TraceabilityNuovo
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6.4 Property and PreservationNuovo
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6.6 Sterile Device ControlsNuovo
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6.7 Implantable Device ControlsNuovo
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6.8 Production Readiness ReviewNuovo
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7. CAPA and Improvement4Lezioni ·
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7.1 Nonconformity ResponseNuovo
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7.2 Root Cause AnalysisNuovo
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7.3 Corrective and Preventive ActionNuovo
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7.4 Effectiveness and EscalationNuovo
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8. Internal Audit Program4Lezioni ·
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8.1 Audit Program DesignNuovo
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8.2 Audit Planning and SamplingNuovo
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8.3 Interviewing and EvidenceNuovo
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8.5 Internal Audit SimulationNuovo
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9. Certification Readiness3Lezioni ·
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9.1 Certification PathwayNuovo
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9.2 Readiness and Gap AnalysisNuovo
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9.3 Management Review EvidenceNuovo
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10. Integrated Application1Lezioni ·
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10.1 Key TakeawaysNuovo
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