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Device Software Function (DSF): FDA’s 2025 AI Draft Definition
“For purposes of this guidance, FDA refers to a software function that meets the definition of a device as a ‘device software function.’”...
May 8, 20253 min read
FDA Import Alerts: A Guide for International Medical Device Companies
An FDA import alert flags products/firms that appear to violate the law and allows detention without physical examination (DWPE) ....
Nov 21, 20244 min read
FDA Warning Letters: What Every Medical Device Company Needs to Know
An FDA warning letter is a public notice that a company significantly violated medical device regulations. Common triggers include QMS...
Sep 20, 20244 min read
How AI is Transforming Regulatory Compliance
Navigating the complex waters of regulatory compliance has long been a challenge for businesses across the globe. As the volume and...
Jul 3, 20245 min read
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