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The 2025 FDA Enforcement Wake-Up Call
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By Marcelo Trevino, independent expert
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FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence.
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The U.K. Now Classifies Ambient Voice Technology As SaMD
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By Benjamin Austin, IMed Consultancy
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The core message of a new guidance issued by NHS England and MHRA is clear: ambient voice technology (AVT) tools that go beyond mere transcription to include summarization are to be classified as software as a medical device (SaMD).
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