The technology platform has already gone global and has the potential to be a true breakthrough in screening and detecting several types of cancer.
Risk Management is the single most important topic impacting the medical device industry today.
CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
Device manufacturers are concerned about data availability and security, as well as risk to their brand.
After preparing for three key issues, follow these recommended strategies when pursuing the market in Japan.
Following these strategies will change how your company works with its outsourcing partners.
In product development, the earliest conceptual time period might be the most important.
As medical device companies move technology concepts into the commercialization stage, collaborating with outside partners is crucial.
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.