Educational Program
Research and Development Professionals, Quality Management Regulators, Technical and Clinical Sectors, Auditors and Consultants of Commercial and Sales’ Sector, Supply Chains from companies or organizations such as:
Course Duration: 1 day
The participants will recognize the basic requirements of the international standard ISO EN 13485:2016 as well as the recent changes based on the renewal of European Legislation by identifying the points of a quality management system.
An explanation is given for the Compliance of Medical Devices based on the ISO EN 13485:2016 standard within the context of the New Regulations and the Quality and Compliance processes of organizations that are active in the Legislative Field of Medical Devices with the addition of practical references to the methodology of approaching the standard application, depending on the case.
It is estimated that this training is necessary for every professional in the sector since it contributes directly to the difficulty of managing the new requirements, to the achievement of a smooth transition of organizations and individuals to the new Regulations and in the emphasis of giving spirit and substance to the implemented changes.
To find out about the cost of the courses, contact us. BQC adjusts its pricing policy for the unemployed and students. Every second participation from the same company will have a 10% discount.
The training methodology includes lectures, practice and teamwork.
In this context, the participants are asked to carry out group and individual exercises, role playing exercises, and evaluation tests that aim to develop their skills (time management, teamwork, cooperation).
In the end, a satisfaction questionnaire is distributed to the participants in order to evaluate the results of their training and the achievement of its objectives.
For the implementation of the training courses, renowned lecturers are selected, with extensive knowledge and experience in the field of Management Systems and, by extension, on the standards.
BQC, by recognizing modern trends in the field of Training, has created a wide network of experts and trainers around the world, which it uses to offer high-level knowledge and experience in the field of Education.
The training courses offered by BQC are certified by the Accredited Personnel Certification Body STAREGISTER, a member of the IPC, thus providing the possibility of issuing accredited certificates of international recognition according to the ISO/IEC 17024:2012 standard to those successfully participating in them.