Introduction & Implementation of ISO 13485 Training Course

• Medical device manufacturer and vendor personnel who will be involved in the launch of management systems or updating of the current management system
• Quality management officers (QMOs), product managers, Regulatory Affairs personnel
• Consultants in the medical device industry

• You will learn how to successfully implement and optimize a QMS based on ISO 13485:2016 in your company.
• You will benefit from the extensive interpretation of ISO 13485:2016 by our experts.

• Introduction to the legal and regulatory environment of ISO 13485:2016
• Legal environment (national and international) and regulatory framework
• Lifecycle of a medical device
• Classification of ISO 13485:2016
• ISO 13485:2016 in detail
• Process validation and risk analysis, documentation
• Qualification and infrastructure
• Development (design control, clinical data, validation)
• Vendor management
• Production management
• Continuous improvement process (CIP): internal errors, complaints, risks
• Corrective actions, preventive measures
• Corrective and Preventive Actions (CAPA), reporting process
• Deepening of the standard section in a practical workshop

• Course delivered by one of TÜV SÜD's leading industry experts
• Small class sizes enhance trainer-delegate relationship
• Receive globally recognised TÜV SÜD certificate upon completion

Upon completion, you will receive your globally recognised TÜV SÜD certificate on Introduction & Implementation of ISO 13485.