Shows
Medical Device made Easy PodcastHow deepeye Medical overcame the AI ACT?
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.
Who is Carmen Bellebna?
Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory fr...
2025-05-2200 minMedical Device made Easy PodcastHow deepeye Medical overcame the AI ACT?
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.
Who is Carmen Bellebna?
Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory fr...
2025-05-2200 min
Medical Device Insights2025-07: AI Act – Ein PraxisberichtVon der Umsetzung bei einem Startup lernen
Die Direktorin "Global Regulatory Affairs", Carmen Bellebna, berichtet darüber, wie sie und ihr Unternehmen DeepEye die Anforderungen des AI Act erfüllen. Keine Theorie, sondern Praxiserfahrungen aus erster Hand. Vom Schreiben von SOPs über Aufwandsschätzungen bis zum Umgang mit Benannten Stellen.
Sie finden auf dieser Webseite eine Übersicht über die regulatorischen Anforderungen einschließlich der Normen an Medizinprodukte und IVD, die Verfahren der künstlichen Intelligenz verwenden.
Wenden Sie sich bei weiteren Fragen an
Carmen Bellebna von DeepEye
Prof. Dr. Christian Johner (via Kont...
2025-05-0528 min