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Current Expertise
current expertise
Background & Credentials
background and credentials
Learning & Interests
learnings and interests
Function:
key account managementIndustry:
Medical DevicesCore Domain Expertise
Previous Companies
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In January 2025, the U.S. FDA released landmark guidance on AI-enabled medical devices, signaling a major shift in how adaptive algorithms will be regulated. At its core is the Predetermined Change Control Plan (PCCP), allowing developers to predefine model updates while ensuring safety and transparency across the product lifecycle. The move not only provides clarity for innovators and clinicians but also builds investor confidence, marking a new era where speed, trust, and patient safety converge in digital health.
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