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Two European devicemaker trade groups, one German and the other French, have joined the chorus calling on the European Union to postpone implementing its Medical Device Regulation (MDR), which took effect May 26, 2021, with a three-year transitional period that will end May 26, 2024. Read More
An auditor or inspector can quickly get a sense of the quality of an investigation by looking at the number of events where “training” was the corrective action. Training is often the default solution because “human error” was the designated root cause. Read More
LumiThera has announced positive 13-month findings from its LIGHTSITE III clinical study in which patients with dry age-related macular degeneration (AMD) were treated with the company’s Valeda light delivery system. Read More
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance. Read More
San Diego, Calif.-based Biological Dynamics’ Verita blood test detected 96 percent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers in a pilot study, the company said. Read More
Nyxoah’s Genio nerve simulation system significantly reduced the severity of sleep apnea, according to the latest, nonpeer-reviewed results from a human study. Read More
What if you can’t determine the root cause of a problem in your manufacturing facility? Without a known root cause, it’s difficult if not impossible to specify effective corrective actions. Corrective actions, meant to prevent or in risk-management terms, reduce the likelihood of occurrence to as low as possible need to align with the root cause(s). Read More