Latest / Medical Device made Easy Podcast
Life After CE Marking: Why AI Medical Devices Need Continuous Monitoring
Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.
In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.
CE Certification Is Not the Finish Line
Many companies assume that once their device is certified, the main regulatory burden is over.
In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI…
The skinny
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