A single-source approach could eradicate data duplication, inconsistencies, and costly human error.
Regulatory and Compliance
Audrey Turley, of Nelson Labs, will speak at Medical Design & Manufacturing Minneapolis about biocompatibility issues related to medical devices including the move to more in vitro testing and the 2020 deadline for the new European Medical Device Regulation.
The decision to suspend its TempSure Vitalia system based on FDA concerns about vaginal rejuvenation procedures is expected to hurt Hologic's fourth-quarter revenue projections by $15 million.
The MDET has been up for repeal or reform more than a dozen times—what are the chances it will be abolished any time soon?
A design change involving replacement parts for a commonly used CPAP mask has triggered a Class I recall for Compass Health.
Be sure to understand when to seek FDA approval and when to seek IP protection, among other insights from an IP attorney.
MD+DI asked for reader feedback on the recently-released Netflix documentary, The Bleeding Edge, and our community did not disappoint.
FDA's five-pronged Medical Devices Safety Action Plan, revealed in April, has triggered concern by AdvaMed, Johnson & Johnson, and physician specialty groups.