HSA
The new article describes in detail special regulatory requirements concerning software medical devices utilising Artificial Intelligence technology to ensure the specific risks associated with it are duly addressed.
FDA
The new article describes in detail the approach to be followed when evaluating medical devices impacting, intentionally or unintentionally, the temperature of human tissues.
FDA
The article provides a general overview of the existing legal framework, highlighting the key points to be considered by the parties interested in placing their products on the US market.
Canada
The new article outlines the key considerations based on the class of the medical devices in question under the applicable risk-based classification system.
HSA
Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue opportunities. However, expanding operations and reaching new countries can be highly challenging for these...
