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FDA device registration and listing is a mandatory annual process where medical device companies register their facilities and list their...

FDA compliance for medical devices isn't optional - it's the gateway to the largest medical device market. In the US, “FDA compliance”...

A combination product combines a medical device with a drug, biologic, or both as a single-entity , co-packaged , or cross-labeled...

A predicate device is a legally marketed U.S. device with the same intended use and technological characteristics that do not raise...

Importing medical devices into the United States requires strict FDA compliance, and the stakes are massive. Medical device importers...

FDA requires medical device labeling to include manufacturer information, intended use, adequate directions, warnings, UDI (where...

Whether you need FDA approval, FDA clearance, or no regulatory submission at all depends on your device's risk classification and...

Medical device companies expanding globally face a critical strategic decision: which regulatory pathway offers the fastest, most...

A medical device Quality Management System (QMS)  proves you can consistently design, make, and support safe, effective devices. It's...