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Catch Up with European Standards in Medical Devices! Mastering the latest information and requirements is crucial for professionals in the medical device sector. The 2017/745/EU Medical Device Regulation outlines the regulations in this area.
The aim 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. Successful
This training is designed to help you understand the scope and requirements of the ISO/IEC 17021-1:2015 standard. The training will provide general information about the fundamental principles of the standard and the process of management system audits an
The purpose of the ISO 19011:2018 training is to assess the compliance and effectiveness of quality management systems with planned arrangements and the requirements of applied standards, specifically for internal auditors and auditors involved in supplie
ISO 14971 Application of Risk Management to Medical Devices Training aims to effectively implement risk management processes for medical devices. The training starts by introducing the scope and fundamental principles of the ISO 14971 standard. Participan
The training provides comprehensive information on the fundamental concepts and applications of the ISO 10993-1 standard. It begins with an overview of the importance of biological evaluation for medical devices and how this process is conducted. Particip
We can define IAF (International Accreditation Forum) as a worldwide association of accreditation bodies and other organizations involved in conformity assessment in areas such as management systems, products, processes, services, personnel, verification
The purpose of this training is to comprehensively convey the requirements of the ISO/IEC 27001:2022 Information Security Management System (ISMS) standard to participants in a practical manner. The training covers the protection of information assets in
The purpose of this training is to comprehensively convey the requirements of the ISO 17665:2024 standard for the sterilisation of medical devices using moist heat (steam) to participants in a practical manner. The training covers the development, validat
The purpose of this training is to comprehensively convey the requirements of the ISO 11137 series of standards relating to the radiation sterilisation of healthcare products to participants in a practical manner. The training covers the fundamentals of g
The aim of this training is to comprehensively convey the requirements of the ISO 11135:2014 standard for the sterilisation of medical devices with ethylene oxide (EO) to participants in a practical manner. The training aims to provide technical competenc
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