Educational Program

MDR 745/2017 and IVDR 746/2017

Standard Requirements of Conformity of the Medical Devices Quality Management System (MDQMS)

Regulatory Research and Development Professionals, Quality Management, Technical and Clinical Sector, Auditors and Consultants from companies or organizations such as:

  • Medical device supply chains (designers, manufacturers, importers, maintainers)
  • Healthcare providers (hospitals, clinics, medical practices, diagnostic laboratories)
  • Companies involved in medical devices as a secondary activity (pharmaceutical, cosmetic, biocidal, etc.)
  • Consultants, agencies, auditors, service providers, health innovation organizations (research centers and laboratories of universities dealing with health, start-up and spin-off companies, federations, incubators and reference organizations with action in health)
Information

Course Duration: 0.5 day

The main objective of the course is to inform and raise awareness of all professionals in the broader healthcare sector regarding the changes brought by the new European Medical Device Regulations MDR 745/2017 and IVDR 746/2017, in the basic compliance requirements of a Quality Management System I/P MDQMS according to MDR 745/2017 and IVDR 746/2017.

The participants will recognize the changes in the legislation and identify the points of a quality management system affected by them.

An explanation is given of the Medical Device Compliance 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 compliance on a case-by-case basis.

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 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 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.

  • Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, (application date: 26th of May 2021)
  • Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (application date: 26th of May 2022)
  • Approved MDCG directives (relating to marketing, as well as references to relevant MEDDEVs, consensus statements and informative documents – factsheets)
  • Substitution (in force as applicable in cases of product categories in a transitional period and other relevant references): Directive 93/42/EEC on medical devices: harmonization of National Legislation: DY8d/G.P.oik130648/Government Gazette 2198B/02-10-2009
  • Directive 90/385/EEC on active implantable medical devices: harmonization of National Legislation: DY8d/G.P.oik130644/Government Gazette 2197B/02-10-2009
  • Directive 98/79/EC – 27/10/98 (for in vitro diagnostic medical devices): harmonization: DY8d/G.P.oik3607/892/Government Gazette1060Β’/10-8-01
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Available Courses

03/02/2025
Standard Requirements of Conformity of the Medical Devices Quality Management System (MDQMS) according to MDR 745/2017 and IVDR 746/2017

Why choose BQC

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.

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