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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
Boston Scientific has issued updated warnings for 16 of its pelvic mesh products, labeling meshes as permanent implants and warning of complications associated with removal. Read More