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Online workshop: Classification of medical devices and certification procedures (Regulation (EU) 2017/745)
| The extent and complexity of the implementation of the requirements of the new Regulation depends on the type, intended purpose, technology, and other characteristics of the medical device. To avoid problems that may result in the inability to supply devices to the market or to use them, medical device manufacturers need to align their quality management system and the devices with the requirements of the new Regulation. |
AimParticipants will learn about the most important changes to the classification of medical devices brought by the EU MDR 2017/745. |
Content
- An overview of the basic differences between the MDD and the MDR with regard to the classification of medical devices.
- Novelties in the requirements for medical device manufacturers regarding medical device conformity assessment or certification procedures.
Target group
- Manufacturers of medical devices.
- Agents/suppliers of medical software.
- Management representatives.
- EU authorised representatives.
- Anyone wishing to acquire or upgrade their knowledge of the MDR.
Workshop and materials will be in English language.
 | Lecturer Uroš Tacar has more than 28 years of experience in medical devices and in the field of development and legislation. He participated in the establishment of the quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of development manager and representative of the quality management. Among the most important tasks, he led the production and maintenance of technical folders of medical devices. He is a consultant and works at SIQ as a lecturer and long-term assessor in the field of medical devices. |
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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