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Documentation for pouch sealing validation conducted by a contract manufacturer lacked a validation protocol, validation activities, raw data, equipment used and a final report. Read More
The deal nets Canady a robotic needle holder and a 5mm motorized articulated surgery device that enables access to intra-abdominal areas, among other items. Read More
The assay has the ability to give urologists a more accurate, genetically informed understanding of a man’s risk for prostate cancer using a urine sample. Read More
Devicemakers that participate in the Medical Device Single Audit Program (MDSAP) should not have to undergo notified body certification, the committee says. Read More