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
| Sorumlu | Rehaf Foula |
|---|---|
| Son Güncelleme | 18.10.2026 |
| Üyeler | 1 |
Health
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1. Standard Orientation1Dersler ·
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1.1 WelcomeYeni
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2. Structure and Context2Dersler ·
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2.1 Purpose and ApplicabilityYeni
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2.2 Clause ArchitectureYeni
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3. Risk and Regulation5Dersler ·
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3.1 Risk-Based FoundationsYeni
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3.2 Risk Management InterfacesYeni
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3.3 Regulatory ResponsibilitiesYeni
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3.4 Market and Jurisdiction ControlsYeni
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3.5 Records and EvidenceYeni
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4. Design and Development6Dersler ·
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4.1 Design Planning ControlsYeni
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4.2 Design Inputs and OutputsYeni
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4.3 Design Review DisciplineYeni
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4.4 Verification and ValidationYeni
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4.6 Design Records and FilesYeni
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4.7 Design Control AssessmentYeni
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5. Supplier and Purchasing Controls3Dersler ·
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5.1 Supplier ClassificationYeni
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5.2 Purchasing InformationYeni
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5.3 Supplier Control PlanYeni
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6. Production and Special Processes7Dersler ·
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6.1 Production PlanningYeni
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6.2 Work Environment ControlsYeni
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6.3 Device Identification and TraceabilityYeni
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6.4 Property and PreservationYeni
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6.6 Sterile Device ControlsYeni
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6.7 Implantable Device ControlsYeni
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6.8 Production Readiness ReviewYeni
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7. CAPA and Improvement4Dersler ·
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7.1 Nonconformity ResponseYeni
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7.2 Root Cause AnalysisYeni
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7.3 Corrective and Preventive ActionYeni
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7.4 Effectiveness and EscalationYeni
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8. Internal Audit Program4Dersler ·
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8.1 Audit Program DesignYeni
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8.2 Audit Planning and SamplingYeni
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8.3 Interviewing and EvidenceYeni
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8.5 Internal Audit SimulationYeni
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9. Certification Readiness3Dersler ·
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9.1 Certification PathwayYeni
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9.2 Readiness and Gap AnalysisYeni
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9.3 Management Review EvidenceYeni
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10. Integrated Application1Dersler ·
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10.1 Key TakeawaysYeni
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