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Establishing operational limits is a key issue to consider. These are the limits that are obtained during the operational qualification (OQ) testing over the expected operating range. So for instance, this applies to equipment and cleaning practices over the expected range, the history or the variety of products that you’re running. Read More
Philips is in discussion with the Department of Justice (DOJ) over a consent decree relating to the company’s June 2021 recall of millions of continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices. Read More
In a draft guidance released yesterday, the FDA recommended improvements in patient labeling information on laser-assisted in situ keratomileusis (LASIK) devices so patients can better understand the benefits and risks involved. Read More
ReCor Medical announced that its Paradise ultrasound renal denervation system has met its primary efficacy endpoint in a pivotal clinical trial as a treatment for hypertension. Read More
An artificial intelligence (AI) platform that evaluated early signs of infection in hospitalized patients reduced death from sepsis by more than 18 percent, according to researchers at Johns Hopkins University. Read More
Medical device trade group AdvaMed and dozens of diagnostics and device firms are urging Congress to include diagnostics reform provisions in the FDA user fee reauthorization package that is currently awaiting a Senate vote. Read More
A Failure Modes Effects and Criticality Analysis (FMECA) begins with planning — and the FMECA plan should define the objectives and scope of the analysis and identify the desired outcome. Read More
More than 85 percent of previously certified devices in the EU are not yet certified under the Medical Device Regulation (MDR) and the certification process is taking twice as long as it used to, according to a new MedTech Europe survey. Read More