Educational Program
Professionals in Research and Development, Regulatory, Quality Management, Technical, Clinical, Inspectors, Consultants from companies or organizations such as:
Program Duration: 1 day
The main objective of the program is to inform and raise awareness of all professionals in the broader healthcare sector regarding the changes brought about by the new European Medical Device Regulations MDR 745/2017 and IVDR 746/2017, in the basic requirements of a Medical Device technical file according to MDR 745/2017 and IVDR 746/2017.
Participants will recognize the changes in the legislation and identify the points of the technical documentation of the products that are affected by them.
An explanation is given of Medical Device Compliance within the framework of the New Regulations and the processes of the organizations that contribute to the creation, maintenance and interpretation of sections of technical files.
In addition, practical references are made to the methodology for approaching compliance on a case-by-case basis.
It is estimated that this training is essential 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 inquire about the cost of the courses contact us. BQC adjusts its pricing policy for the unemployed and for students. Every second 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 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.