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U.S. Health Regulators Issue Alerts on Device Reprocessing
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MDIC Eyes New Quality Metrics to Move Beyond GMP
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FDA Outlines Label, Test Expectations for Products Containing Heparin
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AG Industries Warned on MDRs, GMPs After Nebulizer Shocks Child
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Unannounced Inspections Await Chinese Device Manufacturers
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EMA to Review Medtronic Implant in Wake of Inspection
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MHRA Details Thinking Regarding Remanufacture of Single-Use Devices
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Draft Guidance Puts Spotlight on Safety in MRI Environment
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Two Companies Fined in Defective Syringe Case
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Expert Advice on Getting CAPA Right
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Bard Hit With Warning Letter Over Unapproved Devices, Quality Issues
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FDA Looks to Ease Stakeholder Confusion Over UDI Direct Marking Requirements
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