Our Training Content
The purpose of the training is to provide participants with knowledge about EN ISO 13485:2016 Medical Devices Quality Management Systems and to train competent auditors who can play an effective role in the audit cycles required by these standards. Participants who successfully complete this training will be able to systematically and objectively evaluate EN ISO 13485 standards and quality management systems, possess the necessary knowledge for auditing, and perform effectively in both internal and external audits.
Basic Principles and Objectives of the Standard
- Basic Principles of ISO 13485:2016
- Purpose and Importance of Quality Management Systems (QMS)
- Role of Quality Management Systems for Medical Devices
- Benefits and Goals Provided by the Standard
Training Methodology
Interactive Presentations: Dynamic and interactive presentations prepared by experts in the field.
Current Information: Learning with real-world scenarios and case studies.
Question and Answer Sessions: Interactive sessions where participants can share their questions directly with instructors.
Assessment Tests: Tests on the reinforcement of knowledge and regulation information.
Who is it Suitable For?
- Professionals Interested in Quality Management Systems
- Medical Device Manufacturers and Distributors
- Internal and External Auditors, Technical Experts
- Quality Assurance and Compliance Managers
- Employees and Related Individuals in the Medical Device Sector
Training Dates and Registration
Our trainings are conducted online and offer flexible time slots. For registration and more information, you can visit our website or contact us via support@pcatrainings.com.tr.
What Will You Gain from the Training?
Mastery of ISO 13485:2016 Standards: Participants will gain a detailed understanding of the scope and requirements of ISO 13485:2016 standards, achieving complete mastery of these standards.
Application and Management of Quality Management Systems: The training teaches participants how to effectively implement and manage quality management systems, allowing them to optimize processes.
Effective Auditing and Internal Audit Techniques: Participants will learn effective auditing techniques applicable to internal and external audit processes, gaining the ability to conduct these processes more efficiently.
Risk Management and Process Improvement Skills: The training covers risk management strategies and process improvement techniques, enabling participants to effectively manage potential risks and continuously improve processes.
Ability to Ensure Compliance with Standard Requirements: Participants will acquire the necessary knowledge and skills to ensure compliance with ISO 13485:2016 standards, guaranteeing their organization’s compliance.
At PCA Eğitim Enstitüsü, we are here to support your success in the industry by providing the most comprehensive and up-to-date training on ISO 13485:2016 Medical Devices Quality Management Systems.
PCA Training Institute is a pioneering online training platform that aims for excellence in digital training in various fields of expertise. By breaking down the boundaries in training, we offer innovative solutions to facilitate professionals worldwide in accessing knowledge and skills.
Without compromising our principles of impartiality, independence, and confidentiality, we aim to lead not only in Turkey but also in the global market, expanding our international network every day.
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