ISO 13485, Training, Medical Devices

Course Objective

• Understanding of the ISO 13485 foundation
• Understanding of the importance of ISO 13485 to an organization
• Understanding the requirements of the ISO 13485 that is relevant to shop floor employee

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

Course Objective

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

Course Objective:

• Understanding of the ISO 13485 Internal Audit requirements
• Understanding the audit principles
• Practical skills necessary to plan, conduct, report and close out an internal audit