Training Objective

The objective is to provide information in such a way that a manufacturer can identify hazards related to medical devices and accessories, including in vitro diagnostic medical devices (IVDs), estimate and control their risks, monitor the effectiveness of these controls, and establish a method for these activities. The requirements of the standard can be applied to every stage of the medical device life cycle.

Who Should Attend

• Risk Managers
• Validation Engineers and Managers
• Quality Engineers involved in validation activities
• Project Managers involved in design and development
• Design and Production Engineers
• Medical Doctors
• Those working for manufacturers, distributors, and dealers related to medical devices, especially due to the diversity of stakeholders including healthcare institutions, industry, patients, and citizens
• Quality Assurance and Quality Control engineers and managers assigned to customer complaints or Corrective and Preventive Actions
• Quality Auditors

Training Content

• What are the terms and definitions?
• General Overview of the Risk Management Process
• What is a risk policy? How is it prepared?
• How is a risk management plan prepared?
• How is the ISO / TR 24971 Annex-A Questionnaire answered?
• What are the risk analysis techniques?
• In which situations are these techniques used?
• How is risk evaluation carried out?
• How is production and post-production information collected?
• How is the process of the impact of this information on risk analysis managed?
• What are the rationales for the requirements?
• What is Risk-Benefit Analysis? How is it performed?
• How is a risk management report written?
• Case study covering applications
• How is the review of the risk management process for medical devices carried out?

What Is Gained Through Risk Training

ISO 14971 Risk Analysis Training addresses this process in detail, which is an important component of risk management. The training begins by providing participants with a general overview of risk management. Then, how to prepare the risk management file and the content of this file are examined in detail. Risk evaluation is at the center of the risk management process and is especially emphasized in this training. Participants gain knowledge on identifying, evaluating, and classifying potential risks. Risk control and risk measurement steps are also covered in detail, enabling participants to learn how to apply these processes effectively. The training also includes important steps such as residual risk evaluation and review of the risk management process. Participants gain the skills required to better understand and continuously improve the risk management process. Topics such as risk calculation, production and post-production risk control are also within the scope of the training. This training guides participants on risk reduction strategies and effective risk management techniques. ISO 14971 Risk Analysis Training helps participants develop safer products and processes by providing in-depth knowledge and skills in the field of risk management.

ISO 13485:2016 Medical Device Quality Management System Training

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 special requirements of the quality system for those working in the field of medical devices. ISO 13485 is a standard that guides the definition of 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 covering 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 our 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

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

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.

What Is Gained with ISO 13485:2016 Training

ISO 13485 Documentation Training provides comprehensive knowledge for medical device manufacturers and relevant professionals on how documents and records should be effectively managed. This training explains what the documentation required by the ISO 13485 Quality Management System standard is and how it should be prepared. Documents include written materials, while records refer to written documents that keep the results and traces of activities. The ISO 13485 standard requires medical device manufacturers to organize, protect, and retain these documents and records. This training provides participants with guidance on how documentation complying with ISO 13485 requirements should be prepared, organized, and maintained. The training also addresses update and revision processes, emphasizing the importance of keeping documents and records up to date. ISO 13485 is a standard that guides the definition of 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 covering 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.

Regulation Trainings

MDR: 2017/745 Medical Device Regulation Training

The 2017/745/EU MDR Medical Device Regulation Training helps you gain an in-depth understanding of the medical device regulation, from the definition of medical devices to conformity assessment methods and product risk classification. This training provides the essential information medical device manufacturers need to develop and place compliant products on the market. By helping you understand the innovations and requirements introduced by the MDR Regulation, it helps you optimize processes in medical device manufacturing.

• Definition and Classification of Medical Devices
• Conformity Assessment Methods and Procedures
• Product Risk Classification and Risk Management
• Technical File Preparation and Content
• Medical Device Labeling and Documentation Requirements
• Product Safety and Clinical Evaluation
• Placing on the Market and Compliance Process with the MDR Regulation
• Monitoring Relevant Regulations and Updates

MDR: 2017/745 Medical Device Regulation Information and Documentation Training Content

• Topics that will help you determine your roadmap and strategy during the transition process
• Issues that you need to change as medical device manufacturers together with MDR
• Definition of Medical Device
• Medical Device Classification
• Risk Management Process
• PMS & PMCF
• The importance of the quality management system in medical device regulation
• Medical Device Safety and Performance Requirements
• Clinical Data Evaluation
• EUDAMED
• Important dates in the transition process
• UDI
• What you need to do to ensure compliance for the transition process to MDR
• What you need to know about products in accordance with MDR (MDR 2017/745/EU) rules
• The new communication to be established with Certification Bodies
• Preparation of technical files and documentation for your Medical Device

Who Should Attend

• Management, Product Managers, and Employees who will transition from MDD to MDR
• Those who want to have basic knowledge about MDR
• Those who want to specialize in MDR
• Those who want to provide consultancy on MDR
• Those who want to become trainers on MDR
• Personnel responsible for MDR
• Quality Assurance and Quality Control Personnel
• Production, Clinical, and R&D Personnel
• Management, Product Managers, and Employees of organizations obliged to comply with MDR