Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform
“The deal will help Stryker significantly accelerate [its] digital aspirations to improve the lives of caregivers and patients,” according to company Chair and CEO Kevin Lobo.
The center is also hoping to move back into more normal review timelines next year.
The agency is encouraging medical device manufacturers to evaluate their risk and take action to remediate any vulnerability.
Enter Killware. As cyberattacks continue to increase in healthcare, medtech companies need to make sure their essential software is up to date. This Q&A with Brian Wrozek of Optiv Security takes a look at how medtech companies and healthcare organizations can address this threat.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
Quarterly recall events increased for the first time since Q2 2020.
The pandemic put unprecedented pressure on drug and medical device production, underlining the growing challenge of monitoring, analyzing, reporting and acting on quality. It became clearer than ever before that the more fragmented processes become, the more critical it is that they can be assessed and managed for consistent quality. At the same time, innovative tools and best practices have emerged.
President Biden intends to nominate former FDA Commissioner Robert Califf, M.D. as agency head, and the same opposition voiced during his previous nomination remains.
For private equity and venture capital investors alike, there are five key trends presenting both headwinds and tailwinds that may impact investment flows into 2022.
