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Trilliant Cited for Failure to Establish Adequate CAPA, Design Validation
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Disconnect Between Management, QCU Possible Source of Warning Letters
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Effective Internal Audits and Quality Control Units for Devicemakers
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Unique Device Identifier (UDI) Rule Implementation and Compliance Guide
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6 Steps to a Stress-Free eMDR Rollout
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Using ISO 11607 to Develop Risk-Based Device Packaging
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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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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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