★★★★★
"The structure, the practice exams, the instructor — all top tier. Passed first try."
AS
Ranjan PradhanSenior Project Manager
— The journey
Course Outline
What the programme covers, module by module.
Module 1: Introduction to ISO 13485
- ISO 13485 overview
- Purpose and scope
- Medical device industry
- Quality management concepts
- Regulatory environment
- QMS benefits
Module 2: Understanding ISO 13485 Requirements
- Structure of ISO 13485
- Key requirements
- Process approach
- Regulatory requirements
- Customer requirements
- QMS effectiveness
Module 3: Quality Management System
- QMS processes
- Process interactions
- Quality objectives
- Organisational responsibilities
- Outsourced processes
- QMS maintenance
Module 4: Documentation Requirements
- Quality manual
- Quality procedures
- Work instructions
- Medical device files
- Document hierarchy
- Documentation practices
Module 5: Document & Record Control
- Document approval
- Document review
- Revision control
- Document availability
- Record retention
- Record protection
Module 6: Management Responsibility
- Management commitment
- Customer focus
- Quality policy
- Quality objectives
- Roles and responsibilities
- Management representative
Module 7: Resource Management
- Human resources
- Competence
- Training
- Infrastructure
- Work environment
- Contamination control awareness
Module 8: Risk Management in Medical Devices
- Risk management principles
- Risk identification
- Risk evaluation
- Risk controls
- Risk-based decision-making
- Lifecycle considerations
Module 9: Product Realisation Planning
- Product requirements
- Quality planning
- Customer requirements
- Regulatory requirements
- Process planning
- Quality records
Module 10: Design & Development Controls
- Design planning
- Design inputs
- Design outputs
- Design review
- Verification and validation
- Design changes
Module 11: Purchasing & Supplier Controls
- Supplier selection
- Supplier evaluation
- Purchasing information
- Supplier monitoring
- Purchased product verification
- Supplier performance
Module 12: Production & Service Controls
- Controlled production
- Work instructions
- Process parameters
- Equipment controls
- Cleanliness requirements
- Service activities
Module 13: Process Validation & Traceability
- Process validation
- Validation criteria
- Identification
- Traceability
- Product status
- Product preservation
Module 14: Customer Feedback & Complaint Handling
- Customer feedback
- Complaint receipt
- Complaint evaluation
- Complaint investigation
- Regulatory reporting awareness
- Complaint records
Module 15: Nonconformity & Corrective Action
- Nonconforming products
- Identification and segregation
- Investigation
- Root cause analysis
- Corrective actions
- Effectiveness review
Module 16: Monitoring, Auditing & QMS Improvement
- Process monitoring
- Product monitoring
- Quality data analysis
- Internal audits
- Management review
- Maintaining QMS effectiveness
— 01.2 · Is it right for you?
Who it's for & what's included
Pick a delivery method to see exactly who it suits and everything you receive.
Who it's for
Classroom
Best for learners who want face-to-face tuition and to network with peers in person.
What's included
Everything you get
- ✓ Live instructor on-site
- ✓ Printed workbook & materials
- ✓ Group exercises & case studies
Who it's for
Online Instructor-Led
Best for learners who want a live instructor and a fixed schedule, without the travel.
What's included
Everything you get
- ✓ Live instructor via video call
- ✓ Digital workbook & resources
- ✓ Session recordings
Who it's for
Self-Paced
Best for self-motivated learners who need maximum flexibility around work and life.
What's included
Everything you get
- ✓ On-demand video lessons
- ✓ Interactive quizzes
- ✓ 24/7 access on any device
— About this course
Course Overview
The ISO 13485 Medical Devices Quality Management Foundation program provides working professionals with foundational knowledge of quality management systems for the medical device industry. Participants learn ISO 13485 structure and requirements, regulatory considerations, QMS documentation, management responsibilities, resource management, risk management, design and development, purchasing, production controls, validation, traceability, customer feedback, complaint handling, nonconforming products, corrective actions, internal audits, and management review.