Discover the hot topics around medical devices

We have built interesting new sessions to cover the hot topics about the present and future of medical devices. “I’m excited to chair the new sessions under the theme ‘Developing Health Technology’. The medical device sessions will dive into the worlds of IVDR, Cybersecurity, Usability, and Artificial Intelligence,” says one of the session chairpersons, Development Manager Mika Siitonen from Labquality. Discover the highlights of the new sessions below.

What’s going on with IVDR?
This session provides you with information and insights of experience in preparation for IVDR compliance from manufacturers’ and competent authority points of view. IVD regulation changed the world of IVD devices to far stricter than before. The transition period is ending and therefore manufacturers as well as competent authorities and notified bodies feel the rising pressure to implement the changes. The session topics focus on the areas where major efforts are required and where room for own interpretation might be feasible even at the last minutes of the transition period.

Digital future part I – Cybersecurity
Medical devices will increasingly become based on or related to software. There have been cyber-attacks on healthcare organisations and laboratories, even during the COVID-19 pandemic, which have had a negative impact on their performance during the biggest rush hour. The new MDR and IVDR include vague new requirements for cybersecurity, but there are no harmonised standards or even clear guidance on how to comply with the requirements or what the best practices may be.

Creating good usability
Usability is one of the core elements of a medical device. Well-designed usability enables a good user experience and customer satisfaction. Moreover, the good usability of a medical device secures safety and performance by reducing the possibility or impact of user error. This session goes through the medical device usability development process from the manufacturer perspective considering the most stringent regulatory requirements.

Digital future part II – Artificial Intelligence
Artificial intelligence (AI) has gained a lot of buzz across industries, and it is also gaining ground in the world of medical devices. There are already AI-based medical device solutions on the market, also within the EU. At best, they can help in human tasks or even perform tasks that humans cannot manage. But how can AI be controlled and on what level should it be controlled? What kind of aspects will AI bring to medical device manufacturers?

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