ISO 13485:2016 Awareness Online

Objective

To provide delegates with a thorough understanding of:

• Implementation Methodology & Requirements of ISO 13485:2016
• Documentation Required by ISO 13485:2016

 
Course Description

• Medical Devices Quality Management Concept                                                                         
• Background & Benefits of ISO 13485
• Risk Management (based on ISO 14971)
• Implementation Methodology
• Regulation and Legal compliance
• Quality Policy
  
• Responsibility and Authority
• Management Review
  
• Advisory Notice and Technical File
• DMR (Device Master Record)
• Installation and Servicing Activities
• Cleanliness of Product
• Identification and Traceability
• Sterile Medical Devices
• Customer Property and Preservation of Product
• Work environment and Infrastructure
• Non-conformity Product and Complain Handling
• Feedback, Identification and Traceability
• Data Analysis and Continual Improvement
• Inspection and Test
• Training and Servicing
• Internal Audit
• Corrective and Preventive Action
• Continual Improvement