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Aleš Martinovský
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Join date: Aug 19, 2024
Posts (20)
Oct 1, 2024 ∙ 2 min
Equivalence Principle for Simple Medical Devices
The application of the principle of equivalence to the clinical evaluation of medical devices is particularly challenging.
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Sep 20, 2024 ∙ 4 min
AI Act – Significant Change or Substantial Modification?
We know very well what a significant change of (medical) devices is in the scope of the MDR since the publication of MDCG 2020-3 Rev1.
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Sep 12, 2024 ∙ 3 min
Equivalent medical device and biological characteristics
The use of clinical data of a "similar" medical device based on the principle of equivalence is highly problematic.
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