Educational Program

ISO EN 13485:2016

Introduction to the requirements of the Medical Devices Quality Management System (MDQMS)

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:

  • Medical devices (designers, manufacturers, importers, maintainers, distributors)
  • Healthcare providers (hospitals, clinics, medical practices, diagnostic laboratories)
  • Companies involved in medical devices as a secondary activity (pharmaceuticals, cosmetics, biocidals, etc.)
  • Consultants, agencies, auditors, service providers, health innovators
  • Organizations (such as research centers and university laboratories dealing with health, start-up and spin-off companies, federations, incubators and reference organizations with action in health)
Information

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.

  • EN ISO 13485:2016 A11:2021 (recent publication by CEN and CENELEC with new annexes ZA and ZB linking the standard to the MDR and IVDR requirements)
  • Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, (application date: 26th of May 2021)
  • Regulartion (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (application date: 2th of May 2022)
  • Substitution (in force as applicable in cases of product categories in transition period and other relevant references):
  • Directive 93/42/EEC on medical devices products: 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 products): harmonization: DY8d/oik3607/892/Government Gazette 1060B’/10-8-01
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Ημερομηνία
Πρόγραμμα
Συμμετοχή
13/06/2025
ISO EN 13485:2016 - Introduction to the Requirements of the Medical Devices Quality Management System (MDQMS)

Education Methodology

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.

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