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:
Program 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.
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The teaching methods used include lectures, practical training and group work.
In this context, participants are invited to carry out group and individual exercises and tasks, as well as role playing exercises, aimed at developing their skills (time management, team spirit, cooperation).
At the end, an evaluation test and a satisfaction questionnaire are distributed to the participants in order to evaluate the results of their training and the achievement of its objectives.