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| Is it sufficient for the manufacturer to state before dispatching a batch of products that the product does not carry any risks? Absolutely not, as it is the responsibility of the manufacturer, together with the designer and developer, to manage the risks involved throughout the life cycle of the products. It sounds simple, but the question soon arises: What is a risk anyway? When should a risk assessment be carried out? What is a risk and how to assess it? Is it enough to write down that a certain hazardous situation occurs "frequently" and another "rarely"? What if the risk is too high? |
Aim
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Content
- Requirements for a risk assessment and risk management
- Basic definitions of EN ISO 14971:2019 and tools for conducting assessments and actions
- New developments in the latest edition of the standard – causes and consequences
- Why risk management at all?
- Planning and implementation
- Risk acceptance criteria
- Assessment of residual risks
- Risk versus benefit
- Post-market follow-up
- Documentation review
- Examples and pitfalls
- An overview of the most important points in software development from the point of view of medical directives - practical examples
Benefits of active work
- The workshop relies on active work methods, where the process is discussed and analysed in the light of different examples and questions from the participants.
- You will face a particular challenge, perhaps unusual, but for many the most useful, just before the end of the workshop.
Target group
- Anyone responsible for the development 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.
| | Lecturer 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: bojan.varga@siq.si
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