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The Centers for Medicare & Medicaid Services imposed sanctions on Theranos following a litany of quality control failures for the blood testing company. Read More
The FDA has clarified expectations on unique device identifiers, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form. Read More
The EU’s new medical device regulations will have far-reaching implications for manufacturing and supply chain operations, and the least of which are increased roles and oversight from notified bodies that will directly impact quality management systems. Read More
Failure to establish procedures for quality audits and management reviews landed C-PAP maker Somnowell a May 12 warning letter for numerous quality system violations. Read More
FDA is recommending that device manufacturers redesign heater-cooler devices used in surgeries because cleaning maintenance challenges have been linked to infections and patient deaths. Read More
Failure to set requirements to evaluate suppliers landed Berwickshire Electronic Manufacturing, a UK contract manufacturer, an FDA warning letter. Read More
Not finding the root causes of problems or documenting complaint evaluations landed General Devices, maker of mobile telemedicine systems, a warning letter from the FDA. Read More
FDA is incorporating a risk-based approach for analyzing biocompatibility of medical devices that come into direct or indirect contact with the body. Read More
TYRX, a Medtronic subsidiary and developer of absorbable antibacterial envelopes, received an FDA warning letter for issues with CAPA investigations and change controls. Read More