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
| 负责人 | Rehaf Foula |
|---|---|
| 最后更新 | 2026/10/18 |
| 成员 | 1 |
Health
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1. Standard Orientation1课程 。
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1.1 Welcome新建
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2. Structure and Context2课程 。
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2.1 Purpose and Applicability新建
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2.2 Clause Architecture新建
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3. Risk and Regulation5课程 。
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3.1 Risk-Based Foundations新建
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3.2 Risk Management Interfaces新建
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3.3 Regulatory Responsibilities新建
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3.4 Market and Jurisdiction Controls新建
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3.5 Records and Evidence新建
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4. Design and Development6课程 。
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4.1 Design Planning Controls新建
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4.2 Design Inputs and Outputs新建
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4.3 Design Review Discipline新建
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4.4 Verification and Validation新建
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4.6 Design Records and Files新建
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4.7 Design Control Assessment新建
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5. Supplier and Purchasing Controls3课程 。
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5.1 Supplier Classification新建
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5.2 Purchasing Information新建
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5.3 Supplier Control Plan新建
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6. Production and Special Processes7课程 。
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6.1 Production Planning新建
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6.2 Work Environment Controls新建
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6.3 Device Identification and Traceability新建
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6.4 Property and Preservation新建
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6.6 Sterile Device Controls新建
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6.7 Implantable Device Controls新建
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6.8 Production Readiness Review新建
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7. CAPA and Improvement4课程 。
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7.1 Nonconformity Response新建
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7.2 Root Cause Analysis新建
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7.3 Corrective and Preventive Action新建
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7.4 Effectiveness and Escalation新建
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8. Internal Audit Program4课程 。
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8.1 Audit Program Design新建
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8.2 Audit Planning and Sampling新建
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8.3 Interviewing and Evidence新建
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8.5 Internal Audit Simulation新建
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9. Certification Readiness3课程 。
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9.1 Certification Pathway新建
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9.2 Readiness and Gap Analysis新建
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9.3 Management Review Evidence新建
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10. Integrated Application1课程 。
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10.1 Key Takeaways新建
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