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Factory CRO Acquires MileStone Research Organization, Builds North American Presence

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device and biologics industries. “The merger with MileStone is an important step in building Factory’s operational strength and service range in North America,” said Dirk Meijer, M.D., Ph.D., Factory CEO. “MileStone is an excellent fit therapeutically, as well as culturally, and complements our existing U.S. operations in Austin, Texas, and Princeton,...

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Unique Device Identification (UDI) System – Path toward Global Harmonization?

On Sept. 24, 2013, the Food & Drug Administration (FDA) mandated 78 FR 58786 (the UDI Rule), herewith establishing a unique device identification labeling system in line with the requirements of 21CFR830.20. Medical device labelers must submit product information to...

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Medical apps under the new European MDR

Worldwide 1 out of every 3 internet users currently monitors their health or fitness using an app. This was shown in a recent survey by market researcher GfK. Millions of health-related apps are downloaded every year, and this is expected...

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