Description
IEC62304 and IEC 82304 detail the different aspects related to product realization as per ISO 13485, especially for the verification and validation activities. But what to do with Medical Devices when it comes to Artificial Intelligence or Machine Learning?
How does this impact the verification and validation approach and what is a pragmatic way forward for static Artificial Intelligence, Dynamic Artificial Intelligence or Static Black Box Artificial Intelligence?
Eager to know more, watch this webinar below.
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Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs
This live webinar will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
Vigilance
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