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IMDRF Proposal Explains Use of QMS for Device Software
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Design Risk Analysis, MDR Land Medicomp a Form 483
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Supplier Evaluation, Calibration Issues Bring Custom Ocular a 483
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Siemens Healthcare Gets 483 for CAPA, Complaint Handling
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Czech Republic Sets Stringent Regulations for Devicemakers
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Lensmaker’s GMP, CAPA Violations Bring Warning Letter from FDA
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FDA Warns GVS Filter Technology on Testing, Quality Violations, CAPA
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Single Audit Gets High Marks From First MDSAP Alum
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Most Device Recalls Linked To Labeling, Software Issues
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CareFusion Warned on Handling of Debris, Particulate Matter
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Risk Management Can Help Conform With EU’s MDD, Annexes Z
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Devicemakers Ask FDA to Exempt Health IT From QS Regulations
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