Navigating the complexities of AI technology can be daunting, especially when it comes to the development and launch of AI medical devices. In this insightful on-demand webinar, a [...]
As the wearable tech industry continues to blur the lines between consumer and medical devices, it is critical to understand the top considerations for developing innovative, compliant, and [...]
As an early-stage medical device company, balancing quality assurance, regulatory compliance, and customer feedback can feel overwhelming. That’s where Simbex and Cognidox come in to offer [...]
Regulatory bodies around the world mandate that medical device companies adopt a “risk-based approach” to their design and manufacturing activities, citing ISO 14971:2019 as the gold standard.
The U.S. health innovation landscape is among the largest globally, making it an attractive target for international companies. However, navigating this landscape can be complex and confusing to [...]
Regulatory FDA finalizes guidance on how clinical decision support software is regulated FDA has published final guidance on determining whether clinical decision support software is considered a [...]
Regulatory FDA creates new category of OTC hearing aids, issues PSAP guidance FDA finalized a much-anticipated rule that allows certain air conduction hearing aids to be available [...]
The Upper Valley is home to a growing number of MedTech companies that are changing how we detect, monitor and treat a variety of diseases. Simbex was excited to join the Magnuson Center for [...]
Last year, we shared results from our Commercialization team's joint efforts with the Dartmouth Innovations Accelerator for Cancer (DIAC), a partnership between the Magnuson Center for [...]
