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Dr. Melanie Krueger
Regulatory Affairs & Strategy
MedTech regulatory strategy
with a focus on MDR, FDA
and high-risk devices
Services
Expertise
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MDR & CE marking
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FDA pathways (IDE, 510(k))
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Clinical & global regulatory strategy
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High-risk and combination devices
About
Regulatory Affairs leader with extensive experience in MedTech, with a focus on MDR, FDA pathways and clinical investigations.
Experience across European and US regulatory frameworks, supporting the navigation of complex global requirements from development through clinical phases to market approval.
Focus on high-risk and combination devices, working cross-functionally across R&D, clinical and quality.
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