Tag: medical device regulatory support

Medical Device Import Compliance & Customs Support – XPRO AMERICA

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Ensuring FDA import compliance is essential for foreign medical device manufacturers and U.S. importers to avoid detention, refusal, or penalties at U.S. ports. The FDA enforces strict regulations on medical…

510(k) Premarket Notification & Clearance Support – XPRO AMERICA

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The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate…