IGBS-SBDG · Professional Course
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.
22.2 hours
Guided learning
10 modules
Structured curriculum
37 lessons
Online, self-paced
5,000.00 LE
Course fee
About this course
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.
Course curriculum
Module 1
1. Standard Orientation
- 1.1 Welcome
Module 2
2. Structure and Context
- 2.1 Purpose and Applicability
- 2.2 Clause Architecture
- 2.3 Context Mapping Checkpoint
Module 3
3. Risk and Regulation
- 3.1 Risk-Based Foundations
- 3.2 Risk Management Interfaces
- 3.3 Regulatory Responsibilities
- 3.4 Market and Jurisdiction Controls
- 3.5 Records and Evidence
- 3.6 Regulatory Risk Assessment
Module 4
4. Design and Development
- 4.1 Design Planning Controls
- 4.2 Design Inputs and Outputs
- 4.3 Design Review Discipline
- 4.4 Verification and Validation
- 4.5 Transfer and Change Control
- 4.6 Design Records and Files
- 4.7 Design Control Assessment
Module 5
5. Supplier and Purchasing Controls
- 5.1 Supplier Classification
- 5.2 Purchasing Information
- 5.3 Supplier Control Plan
- 5.4 Supplier Evidence Check
Module 6
6. Production and Special Processes
- 6.1 Production Planning
- 6.2 Work Environment Controls
- 6.3 Device Identification and Traceability
- 6.4 Property and Preservation
- 6.5 Process Validation Principles
- 6.6 Sterile Device Controls
- 6.7 Implantable Device Controls
- 6.8 Production Readiness Review
Module 7
7. CAPA and Improvement
- 7.1 Nonconformity Response
- 7.2 Root Cause Analysis
- 7.3 Corrective and Preventive Action
- 7.4 Effectiveness and Escalation
- 7.5 CAPA Case Review
Module 8
8. Internal Audit Program
- 8.1 Audit Program Design
- 8.2 Audit Planning and Sampling
- 8.3 Interviewing and Evidence
- 8.4 Reporting and Follow-Up
- 8.5 Internal Audit Simulation
Module 9
9. Certification Readiness
- 9.1 Certification Pathway
- 9.2 Readiness and Gap Analysis
- 9.3 Management Review Evidence
- 9.4 Certification Readiness Check
Module 10
10. Integrated Application
- 10.1 Key Takeaways
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