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Regulation and official guidance
Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
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Topics
Private: Test 2
Test 2
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Research and analysis item
Certification of Machine Learning Applications in the Context of Trustworthy AI with Reference to the Standardisation of AI Systems
We review the landscape of AI standards and certification and emphasise their role in the context of trustworthy AI. Third-party…
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