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3 articles

Regulatory

Abbott FDA Device Footprint: Diagnostics, Recalls & PMA Portfolio

A data-driven regulatory profile of Abbott's FDA clearances, PMA approvals, safety recalls, diagnostics division, and global manufacturing hubs in Illinois, California, Germany, and the Netherlands.

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Regulatory

Philips FDA Device Footprint: Clearances, Recalls & Consent Decree

A comprehensive regulatory dossier analyzing Philips' FDA clearances, cardiovascular PMA distribution, recall history under the 2024 consent decree, and global manufacturing plants.

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Regulatory

Netherlands Medical Device Registration and Market Access Guide (2026)

Register and market devices in the Netherlands under EU MDR, including IGJ oversight, CIBG Farmatec, NOTIS, Dutch labeling, EUDAMED, CCMO trials, notified bodies, and PMS.

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