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Online workshop: Guidelines for Managing Medical Device Cybersecurity in Design, Installation, and Maintenance
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| This workshop takes a system approach to protecting medical devices, systems, networks, and applications from digital attacks. As technology evolves, the number of active medical devices connected to the outside world through various links is increasing. There are more and more applications and programmes on the market that function as stand-alone medical devices. New legislation on medical devices has brought additional requirements for managing cybersecurity. Thus, the use of a medical device must take into account its intended purpose and risk class, and potential risks must be managed throughout its life cycle in accordance with the General Safety and Performance Requirements (GSPR) as defined in Annex I to Regulation (EU) 2017/745 (MDR) on Medical Devices. When demonstrating compliance of a programmable active medical device with medical regulations, it is crucial to ensure that the software is compliant and cybersecure, while also ensuring the device’s effectiveness |
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Content
- Brief description of medical regulatory requirements
- Classification of a product as a medical device
- Determining compliance requirements for a product
- Methods for demonstrating medical software compliance
- Descriptions of software as a medical device
- Integration of medical software management processes into the quality management system
- Demonstrating compliance with the requirements of standards and expected documentation
- Overview of the most important steps in software development from a medical regulatory perspective - practical examples
Target group
- Developers of medical devices that incorporate interoperable software.
- Manufacturers of medical software that is either a stand-alone medical device or a component of a PEMS (Programmable Electrical Medical System).
- Agents or suppliers of medical software.
- Responsible persons for the quality and compliance of medical devices.
- IT staff responsible for maintaining the networks on which the medical devices operate.
- IT network maintenance staff in healthcare institutions.
- Anyone wishing to acquire or upgrade their knowledge of ensuring or demonstrating the compliance of medical software.
Course and materials will be in English language.
 | Lecturer Uroš Tacar has more than 25 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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