We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Internal audits can be a great way for a devicemaker to uncover quality issues and improve compliance programs, but there are challenges to doing them. The vast majority of manufacturers conduct internal audits soley because the FDA and ISO regulations say they should, says Susan Reilly, owner of the consultancy Reilly & Associates. That results in poorly conducted audits with little or no added value. During a recent FDAnews webinar, Reilly answered questions about how to design and perform effective internal audits.Read More
GMP violations including failure to submit a premarket approval application for its denture liner and failure to register the device in 2015 prompted an FDA warning letter to Better Health Systems. Read More
The FDA hit Smith & Nephew with a warning letter for quality, CAPA and procedural issues related to its Truclear Ultra Reciprocating Morcellators 4.0. Read More
The study was paused in September after reports surfaced of reduced leaflet motion observations in patients implanted with transcatheter aortic valve devices. Read More
The company received complaints that distinguishing the smooth from rough surface of the device proved difficult, which could lead to major adverse events. Read More