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Online workshop: Risk Based Approach in the production of medical devices



The safety of medical devices is largely based on the processes by which these devices are manufactured. It is therefore essential to be able to identify and manage the risks associated with these processes, as required by the latest edition of EN ISO 13485:2016. It sounds simple, but the following questions soon arise:

  • What is a process risk anyway?
  • Which processes need to be addressed from a risk perspective and when?
  • What is the basis for risk treatment and how is it carried out?
  • How much does experience count in product risk assessment – is the methodology transferable?
  • Which guidelines (standards) can be relied opon?
  • How to maintain effective process risk management in medical device manufacturing?


The workshop will provide participants with the basic definitions and detailed requirements for managing process risks in medical devices.

The focus is on the comprehensive approach as a central requirement of the standard for quality management systems in manufacturing medical devices (EN ISO 13485:2016)


  • Documents – the origin of the requirement and basic concepts
  • Standards and editions addressing process risk management, types of risks
  • Requirements for manufacturers – direct and indirect
  • Guidance for risk-based QMS
  • Introduction of the Risk-Based Approach
  • Product and process risks
  • ISO 31000 – basic guidance; additions required for medical devices
  • Activities of the organization when introducing the Risk-Based Approach (RBA)
  • Definition of a process and procedures
  • Records and examples
  • Comparison with risk management requirements for medical devices

Benefits of active work

  • The workshop relies on active work methods, where the process is discussed and analyzed in the light of different examples and questions from the participants.
  • The examples given and the answers to the questions will be translated into the participants' practice in the development, manufacture, and sale of medical devices.

Target group

  • Anyone who is responsible for the implementation of processes in the manufacture of medical devices.
  • Suppliers of components/sub-assemblies for medical devices.
  • Quality managers in development and manufacturing companies.
  • Representatives, brand holders, and importers of medical products of non-European manufacturers.
  • Anyone wishing to acquire or upgrade their knowledge of CE marking and conformity assurance for medical devices.

Course and materials will be in English language.


Rok Hrovatin PhD started assessing the risk of medical devices only a few years before Slovenia’s accession to the EU. The transposition of European directives has established requirements in this area with the Medical Devices Directive (MDD 93/42 / EEC). He gained experience and knowledge as the head of the testing laboratory for medical devices at SIQ, and soon after that also as a leading auditor in the field of medical devices and as a lecturer in this field.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.  Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail:

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