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Planning and developing an internal audit program and training all involved personnel are tasks that take a lot of time and effort, but they are merely the foundation. Execution of the audit program comes with its own set of challenges and is a more extensive activity than just checking items off a “to do” list in the audit procedures document. Read More
Illumina has launched its cancer diagnostic test, TruSight Oncology (TSO) Comprehensive (EU), in Europe — calling it the first CE-marked in vitro diagnostic (IVD) kit for comprehensive genomic profiling based on DNA and RNA content. Read More
The FDA has posted a warning on its website against using Apyx Medical’s Renuvion/J-Plasma device for aesthetic dermatology procedures, which has caused burns and other serious adverse events. Read More
A critical factor in successful auditing is having the right people conduct the audit, meaning individuals with the right mindset and training to ensure that the audit process is rolled out effectively. Read More
The FDA has issued a Form 483 to Enthermics Medical Systems, based on an inspection last September of the company’s facility in Menomonee Falls, Wis. Read More
San Francisco, Calif.-based ProSomnus Sleep Technologies said that several postmarket studies of its EVO Sleep and Snore Device have shown it be an effective alternative to continuous positive airway pressure (CPAP) therapy in treating obstructive sleep apnea (OSA). Read More
The quality control unit (QCU) must be designed in a way that enables it to see and react to issues as they arise or, better yet, preemptively. The unit must touch all the quality systems regulated by the FDA or other regulatory bodies. Read More