What should medical device companies be doing to mitigate cybersecurity risks? One expert shared his insight on the subject during MD&M West 2019.
Regulatory and Compliance - Industry Insight
Awaiting congressional approval, the United States-Mexico-Canada Agreement could reduce duplicative regulations while increasing intellectual property protections, among other changes.
The New Year offers the chance to review your company’s marketing and sales practices given recent enforcement activity
The EU regulation may have been around for more than a decade, but there is still a lot for medtech to learn.
From 2015 through 2018, about 20% of 510(k) clearances were based on substantial equivalence to a predicate device that was more than a decade old. Should FDA continue to allow this practice, or should older devices be retired as predicates?
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?
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?