Professionals in Research & Development, Regulatory, Quality Management, Technical sector, Clinical sector, Inspectors, Consultants, Commercial/Sales, Supply Chain, from companies or organizations such as:
Training Program Introduction to the Requirements of the Quality Management System I/P MDQMS according to ISO EN 13485:2016
Program Duration: 1 day
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.
They will also identify the points of a quality management system that are affected by them. An explanation is given of the Compliance of Medical Devices based on ISO EN 13485:2016 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.
In addition, practical references are made to the methodology for approaching the implementation of the International Standard ISO EN 13485:2016 as appropriate.
It is estimated that this training is necessary for every professional in the sector and directly contributes to the difficulty of managing the new requirements, to achieving a smooth transition of organizations and individuals to the new Regulations and to the emphasis that is beneficial to give to the spirit and substance of the implemented changes.
To find out about the cost of the programs, contact us. BQC adjusts its pricing policy for the unemployed and students. Every 2nd participation from the same company will have a 10% discount.
The teaching methods used include lectures, practical exercises and group collaboration.
In this context, participants are asked to complete group and individual exercises and assignments, as well as Role playing exercises, which aim to develop their skills (time management, team spirit, collaboration).
At the end, an evaluation test and a satisfaction questionnaire are distributed to participants in order to evaluate the results of their training and the achievement of its objectives.
See the programs we have available
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.