_edited.jpg)
ISO 13485:2016 Medical Device Quality Management Systems
Course Overview
​​​
-
Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours
-
Target Audience: Quality managers, regulatory professionals, medical device manufacturers
-
Certificate: Professional Development Certificate of Completion
Learning Outcomes
Upon completion, participants will be able to:
​
-
Understand the structure and requirements of ISO 13485:2016
-
Implement quality management system processes for medical devices
-
Develop compliant documentation and procedures
-
Prepare for certification audits and regulatory inspections
Module 1:
Foundation and Context
(2 hours)
-
Medical device regulatory landscape overview
-
ISO 13485 vs ISO 9001 differences
-
Quality management system principles
-
Risk-based approach implementation
-
Homework: Gap analysis template completion for participant's organization
Module 2: Documentation and Management Responsibility
(2 hours)
-
Document control requirements (Clause 4.2)
-
Management responsibility and commitment (Clause 5)
-
Quality manual development
-
Management review processes
-
Homework: Create quality policy and objectives for case study organization
Module 3:
Resource Management and Product Realization (2 hours)
-
Resource management requirements (Clause 6)
-
Product realization processes (Clause 7)
-
Design controls and development
-
Purchasing and supplier management
-
Homework: Design control procedure development exercise
Module 4: Measurement and Improvement
(2 hours)
-
Monitoring and measurement (Clause 8)
-
Internal audit requirements
-
Corrective and preventive action (CAPA)
-
Post-market surveillance integration
-
Homework: Internal audit checklist creation and CAPA procedure review
