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Avoid the Consequences of an Experiment Gone Wrong
Avoid the Consequences of an Experiment Gone Wrong
Aug 29, 2017
Linking the experimental process to the design controls defined by FDA can help ensure an effective and efficient new product development effort, as well as a competitive market advantage.
Risk of Wire Breakage Prompts Penumbra Recall
Jul 24, 2017
FDA said 155 devices on the U.S. market are included in a recall of Penumbra's 3D Revascularization device because the delivery wire could break or separate during use.Amanda PedersenPenumbra initiated a voluntary recall of its Penumbra 3D...
Did Magellan Try to Hide its Quality Control Problems?
Jul 13, 2017
Meridian Bioscience's diagnostics unit knew about its faulty blood lead test results for almost three years before FDA caught wind of the problem, the agency noted in its inspection report.Amanda PedersenAt best, Magellan Diagnostics ignored...
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