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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