EN ISO 13485 Quality Management System Training in Medical Devices

Purpose of Training:

The training will inform participants about EN ISO 13485:2016 Medical Devices Quality Management Systems and will guide companies involved in the life cycle of medical devices to establish, optimize and implement their systems in line with this standard.

Content of the Training:

Medical device definitions

quality management system

Documentation requirements

Management's responsibility

resource management

product realization

Measurement, analysis and improvement

Medical device regulation link

Who Should Participate:

• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• People who want to improve themselves in medical device QMS processes
• Consultants

Benefits of Education:

Ability to interpret EN ISO 13485 standards and quality management system systematically and objectively

Ability to determine methods for ensuring and implementing the requirements of the quality management system within the scope of medical device regulation

Ability to identify cost saving methods within the quality management system

Understanding supplier management

Reference Sources:

(EU) 2017/745 Medical Device Regulation

EN ISO 14971

ISO 24971

EN ISO 13485

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:

For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr