ISO 13485:2016 – Introduction and implementation

• You know how to introduce or optimize a quality management system in your company based on ISO 13485:2016.
• You benefit from the detailed interpretation of the ISO 13485:2016 standard 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

• 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

As a participant, you will receive a copy of the standards book „Quality Management and Risk Management for Medical Devices ISO 14971 and ISO 13485“.

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