ISO 13485 Medical Devices Quality Management System
Duration : 2 Days
ISO 13485 MEDICAL DEVICES MANAGEMENT SYSTEM
Objective
To provide delegates with a thorough understanding of:
• ISO 13485 Medical Devices - Quality
Management System
• Proven Implementation Methodology
• Key Success Factors and Obstacles
• Documentation required by ISO 13485
Course Description
•
Medical Devices =Quality Management Concept
•
Background & Benefits of ISO 13485
•
ISO 14971 – Risk Management
•
FMEA Method for Risk Management
•
Implementation Methodology
• Regulation and
legal compliance
•
Responsibility and Authority
•
Advisory Notice
•
DMR – Device Master Record
• Installation
and
Servicing Activities
• Cleanliness of Product, Identification and Traceability, Sterile Medical Devices• Work environment and
Infrastructure
•
Non Conformity Product
•
Feedback, Identification and Traceability
•
Data Analysis and Continual Improvement
• Corrective
and Preventive Action
•
Inspection and Test
•
Training and Servicing
•
Exercise & Feedback of Clauses
•
Workshop Risk Management
•
Case Study
