Commercialization

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 [...]

At Simbex, our holistic approach to product design centers on identifying risk at every stage of the commercialization process from concept to market and planning ahead to lower the level of risk [...]

A Technology Review often begins with early assessment of the technology solution, which entails confirming that the technology is feasible and has not already been developed.

A product requirements document is a collection of the many requirements that will define the expected behavior for an entire product.