"ISO 13485 Medical Devices Quality Management System Requirements Training" is a 2-day comprehensive training in which the process of the ISO 13485 standard according to the Medical devices management system in the sector is discussed one by one with the standard items. The aim of the training is the process approach of ISO 13485 and the standard and GMP. In addition, the participants are informed about the risk management principles defined in ISO 14971: 2007, which is the "Risk Management Practice in Medical Devices" standard. During the training, participants are given practical exercises supported by individual or group studies on the information provided. In addition, the inclusion of the participants in the applications using the brainstorming technique with the case studies included in the training module by the trainer increases the effectiveness of the training.
ISO 13485 Medical Devices Quality Management System Application Training
"ISO 13485 Application" training; discusses the concepts necessary to understand, develop and implement a quality management system as specified in the medical devices standard ISO 13485. This training also addresses the basics of the ISO 14971 standard, which includes key principles of risk management. Experienced trainers will explain how to integrate the ISO 13485 system implementation into the whole business, how to prepare for audits and how to obtain the ISO 13485 certificate. The exercises included in the training will prepare the participants in drafting key requirements, creating documentation, developing project plans and preparing a scope map.

ISO 13485 Medical Devices Quality Management System Internal Auditor Training

"ISO 13485 Internal Auditor" training; It is designed for quality professionals who aim to improve their existing ISO 13485 knowledge and evaluate the effectiveness of the quality management system in their organizations. This two-day intensive training teaches the principles and practices of quality management system process audits to be performed according to ISO 13485 and ISO 19011 standards. Experienced trainers will guide participants through the entire internal audit process, from the preparation of an audit plan, to the reporting of audit results and follow-up of corrective actions. Participants; They will gain the necessary investigation skills through classroom lectures, practical role studies and group workshops.
Who Should Attend
• Quality Managers
• Licensing Unit Managers
Internal auditors of medical device manufacturers
• Functional team members involved in the implementation
Professionals providing inspection services to organizations in the sector