ISO 13485:2016 Medical Device Quality Management System

It is a standard that is necessary to fulfill the requirements of the existing legal requirements of medical device manufacturers, to ensure customer satisfaction, to increase in-house efficiency and to eliminate the problems that may be encountered after sales and to create a legal assurance.
The ISO 13485 standard determines the specific demands required by the quality system for employees in medical devices. ISO 13485 is a guiding standard for identifying specific requirements that quality systems must meet for manufacturers operating in the production, trade and distribution of medical devices.

ISO 13485:2016 is a requirement on Medical Devices that meets customer requirements and covers improvement and development activities, except for legal regulations related to related services.ISO 13485: 2016 is a specially written quality management standard for medical devices. This standard is written in line with the quality management system requirements of the European Union Medical Device Legislation (MDR EU 2017/745) published in 2017.

Who to Join

  • Those who want to increase their competencies in the field of production and quality
  • Those who work or want to work in the health sector or in sectors such as medical device manufacturing, supplier
  • Students or graduates who want to take a step forward in job applications by mastering the standards applied in accordance with ISO standards
  • Those who want to contribute to their professional development and career by mastering the standards applied in the sector
  • Those who work or want to work in quality departments
  • Those who want to master the internationally accepted standards that must be applied in our country
  • Those who want to be instructors in the field of Management Systems
  • In job applications, people who have mastered ISO Management Systems and have received the latest update training and certificates of standards are preferred as a priority.

ISO 13485 Quality Management System Standard

  • Scope
  • References and regulations
  • Terms and definitions
  • Quality management system
  • Management responsibility
  • Resource management
  • Perform a product
  • Measurement, analysis and improvement

To summarize, a manufacturer of medical devices, by applying the requirements of ISO 13485: 2016, can comply with legal requirements and launch safe medical devices efficiently.

Educational Content

  • Certification Procedure
  • Basic Concepts of Quality
  • Organizational Structure in Quality Management Systems
  • Introduction of TS EN ISO 13485 Standard
  • Interpretation of the articles of the TS EN ISO 13485 Standard
  • Practical and Case Studies