SIQ: Online course: Guidelines for Managing Medical Device Cybersecurity in Design, Installation, and Maintenance

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

About the training

This seminar 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

Aim

• You will learn about the requirements of medical device legislation in relation to medical software and gain information on how to manage medical device cybersecurity through practical examples.
• You will address the current challenges and guidelines in the field of cybersecurity in medical devices, which are nowadays increasingly exposed to the risk of cyber-attacks.
• You will learn about best practices in establishing a cybersecurity risk management system and focus on potential measures to be taken in the development, installation, and maintenance of medical devices that incorporate software.
• Through practical examples, you will learn how to identify and prevent cyber-attacks on medical devices.
• You will gain knowledge to help you design, develop, and manage safe medical devices that incorporate software.

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.

Costs

• Standard: 475,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Uroš Tacar has more than 25 years of experience with medical devices and the field of development and legislation. He participated in the establishment of a quality system and in ensuring the compliance of active medical devices. At the manufacturer, he performed the duties of head of development and representative of quality management. Among the more important tasks, he managed the production and maintenance of technical files of medical devices. He currently works as an assessor at SIQ and a consultant in the field of medical devices.

Location: ONLINE

The online workshop will take place in a live online e-classroom. 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.