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DiaSorin gained the rights to commercialize the test for use on its Liaison analyzer platform in the U.S. in a September 2020 licensing deal with MeMed. 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
Biotronik has agreed to pay almost $13 million to settle allegations that it paid kickbacks to physicians to encourage their use of the company’s implantable cardiac devices. Read More
The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Read More
In a final guidance released on Friday, the FDA said it will enforce standard date formatting and Unique Device Identification (UDI) labeling requirements for certain class I and unclassified devices starting on Dec. 8. Read More