Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?
Regulatory and Compliance
It's the halfway point for the three-year transition period between the European Union’s old directive for regulating medical devices, and the new Medical Device Regulation.
A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.
The agency is encouraging innovation in digital health. But is software really so fundamentally different from hardware that it can’t be regulated in the same way?
Industry and FDA are working together to promote actual quality improvement, not just compliance to regulations.
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.