The company is bracing for a $25 million revenue hit after FDA ordered two of its mesh products off the market, but a bigger concern may be lying in wait.
Regulatory and Compliance - Industry Insight
Medical device innovators should pay attention to the recent court case for clues on how courts could view other hybrid inventions such as wearables and more.
An industry expert talks about the role communication and language play in clinical trials and regulatory compliance.
A letter from Senator Mark Warner (D-VA) prompted AdvaMed to reiterate these five principles for addressing medical device-related cybersecurity threats.
Don't miss these technical resources on design validation and human factors, preventing misconnections, implant coatings, and more.
FDA urges collaboration, but healthcare system limitations and FDA guidance prompt medical devices to be secure by design to ensure patient safety.
What should medical device companies be doing to mitigate cybersecurity risks? One expert shared his insight on the subject during MD&M West 2019.
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