Medical Device Trainings

What is Medical Devices Quality Management System Training?

“ISO 13485 Medical Devices Quality Management System Requirements Training” is a 2-day comprehensive training in which the ISO 13485 standard is handled individually with the standard items of the operation according to the Medical devices management system throughout the industry. In addition, the participants are informed about the risk management principles defined in ISO 14971: 2007, which is the standard of “Risk Management Practice in Medical Devices”, during the training, hands-on exercises supported by individual or group studies are provided. Moreover, the inclusion of the participants into the applications by using the brainstorming technique with the case studies included in the training module increases the effectiveness of the training.

Who Should Attend
• Quality Managers
• Licensing Unit Managers
• Internal auditors of medical device manufacturers
• Functional team members involved in the application
• Professionals providing audit services to organizations in the industry
• ISO 13485 understanding the requirements of the standard,
• ISO 13485 and GMP General information about the relationship between the rules. Education Structure
• ISO 13485 Disclosure of all articles of the standard,
• ISO 13485 Explaining the role of management in the implementation of the standard,
• PD CEN ISO/TR 14969 Explain the proper use of the standard,
• Risk Management and ISO 14971 Explanation of the relationship between.

Preliminary Information Required No prior knowledge is required to participate in ISO 13485 Medical Devices Quality Management System Requirements Training, but the participants’ basic quality management system; It will be useful if they have information about ISO 9001 or ISO 13485.