ISO 13485:2016 Interpretation Training

Course Objective

• Understanding what is medical devices
• Basic knowledge on the ISO 13485
• An interpretation of the ISO 13485 requirements

Course Highlight:

• Introduction of the ISO 13485
• The ISO 13485 Evolution
• The ISO 13485 Foundation
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization
• Clause 8: Measurement, Analysis and Improvement

Duration:

Suitable for:

Contact us for the synopsis.