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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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Most Device Recalls Linked To Labeling, Software Issues
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Zoll Warned After Inappropriate Shocks With Medical Life Vest
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Devicemaker Warned on Averaging Supplier Quality, Delivery Ratings
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Participants in Single-Audit Pilot Unlikely to See Warning Letters
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Industry: 510(k) Guidance Should Not Usher in New Data Requirements
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ProTech Warned Over CAPAs, Procedures, Modifications
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Kidney Tray Maker Warned on ID Labels, Quality Lapses
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$25.00
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CareFusion Warned on Handling of Debris, Particulate Matter
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FDA Warns Ventlab Over Nonconforming Material
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AMS Form 483 Notes CAPA, Postmarket Surveillance Slips
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$157.00
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