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MHRA Details Thinking Regarding Remanufacture of Single-Use Devices
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Process Validation: A Guide for Devicemakers
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Design Control, CAPA Lead to Warning Letter for Nuga
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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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Effective Internal Audits and Quality Control Units for Devicemakers
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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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Device Software Safety Risks: Standards Lead to Closer FDA Scrutiny
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Use QSIT to Your Advantage in FDA Device Inspections
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Report Details Risk Management Needed to Conform to EU’s MDD, Annexes Z
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EC Panel Recommends Phased Approach to Risk Evaluation of Nanomaterials
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