What are the requirements for document control and record management under the Quality System regulation?

Mar 7, 2022 ... Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug ... Mar 9, 2022 ... Information that supported 510(k) cleared assays is publicly available! ... What does this mean? • Intended only for Employment and ... It is important to seek feedback from FDA at a time when it will be of most value. o Initiating a pre-submission meeting early might mean that you still have ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 Jan 10; ... Public documents for the 510(k) medical devices were collected using FDA ... Jan 10, 2023 ... Main Outcomes and Measures Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020 ...