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Device Malfunctions Bring Form 483 to Siemens Medical Solutions USA
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Insert Depot Receives Form 483 Over Complaints, Device Records
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Design Control, CAPA Lead to Warning Letter for Nuga
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Trilliant Cited for Failure to Establish Adequate CAPA, Design Validation
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Filtration Systems Manufacturer Receives FDA Warning Letter
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Poor Complaint Handling Lands Insightra Medical Warning
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Disconnect Between Management, QCU Possible Source of Warning Letters
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Experts: Incorporate CyberSecurity Into Design, Development Process
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Malaysian Authorities Aim to Shed Light on Conformity Requirements
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FDA to Scrutinize Essure Implant’s Safety Record
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Devicemakers Forge Program to Accredit Global Suppliers
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China Issues 90 Standards to Raise Device Quality
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