Join us for a webinar on the regulation of software and artificial intelligence in medical technology. MDR, IVDR and the EU Artificial Intelligence Act are placing increasingly detailed requirements on developers of digital health solutions, so a clear understanding of qualifications, classification and compliance is essential early in development.
The webinar will take place on 17 March at 10.00.
The webinar will be moderated by Stefan Bolleininger, CEO of Consultys Medical and Senior Regulatory Affairs Advisor, specialising in early-stage innovation project support and CE marking strategy.
Topics covered in the webinar:
- How to determine whether software qualifies as a medical device or in vitro diagnostic under the MDR/IVDR
- Classification of software and in vitro diagnostic software and its impact on regulatory requirements
- Conformity assessment requirements, including technical documentation, cybersecurity and clinical or performance evidence
- Standards applicable to software and AI, including IEC 62304, ISO 14971 and IEC 82304-1
- Requirements for artificial intelligence and machine learning systems, including data management, transparency and validation
- The interplay between the EU AI Act and MDR/IVDR and the role of double compliance in practice
Norise: Zoom platform
Working language: english
Registration: https://luma.com/dki2q09z
Participants are invited to send their questions by 13 March by e-mail: inovacija@rsu.lv
Please note that the webinar will be recorded.
