Bringing software with a medical purpose to the EU market has become increasingly complex. The MDR, IVDR and upcoming AI Act introduce overlapping requirements that many innovators struggle to interpret. This webinar, organised by Starodub B.V. and GRC B.V., explains how to align your software development and regulatory strategy to achieve smooth and compliant market access.
Our experts will highlight how to determine whether your software qualifies as a medical device or IVD, how to classify AI systems by risk, and what to expect from the transitional timelines of the AI Act. Practical guidance will be shared on how early integration of regulatory and quality requirements can help avoid delays and compliance gaps.
The webinar features Patrick Vronen and Seamus Moore from Starodub B.V., and Monique Greijmans from GRC B.V., who will share their experience supporting MedTech and digital health companies through these regulatory challenges.
To get access to the webinar, please fill in the registration form below with your name and email address. The access link will be sent to you by email.
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