It is a standard applied in the medical device and healthcare sector and determines the framework within which quality management is implemented in this sector. It is necessary for medical device manufacturers to fulfill current legal obligations, ensure customer satisfaction, increase internal company efficiency, eliminate problems that may be encountered after sales, and establish legal assurance. The ISO 13485 standard defines the specific requirements of the quality system for those working in the field of medical devices. ISO 13485 is a standard that provides guidance in defining the specific requirements that quality systems must fulfill for manufacturers operating in the production, trade, and distribution of medical devices. ISO 13485:2016 is a requirement that covers improvement and development activities in addition to meeting customer requirements and legal regulatory requirements related to medical devices and related services. ISO 13485:2016 is a quality management standard specifically written for medical devices. This standard was written in parallel with the quality management system requirements of the European Union Medical Device Regulation (MDR EU 2017/745), published in 2017.

Who Should Attend

• Those who want to improve their competencies in production and quality fields
• Those working or wishing to work in quality departments
• Students or graduates who want to stand out in job applications by mastering standards applied in accordance with ISO standards
• In job applications, people who are familiar with ISO Management Systems and who have received training and certificates on the latest updates of the standards are primarily preferred
• Those who want to contribute to their professional development and careers by mastering the standards applied in their sector
• Those who want to master internationally accepted standards that are mandatory to implement in the country
• Those working or wishing to work in the healthcare sector or in sectors such as medical device manufacturing and supplier companies
• Those who want to become trainers in the field of Management Systems

ISO 13485 Quality Management System Standard

• Scope
• References and regulations
• Terms and definitions
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis, and improvement

In summary, by implementing the requirements of ISO 13485:2016, a medical device manufacturer can ensure compliance with legal requirements and efficiently place safe medical devices on the market.

Training Content

• Certification Procedure
• Basic Concepts Related to Quality
• Organizational Structure in Quality Management Systems
• Introduction to the TS EN ISO 13485 Standard
• Interpretation of the clauses of the TS EN ISO 13485 Standard
• Practical and Sample Studies