EMA
The article provides a brief overview of a consolation document intended to address the key points related to companion diagnostics in the context of the current EU regulatory framework.
Medical Devices
Software as a Medical Device (SaMD) is transforming the future of healthcare, enabling innovative diagnostics, real-time patient monitoring, and advanced clinical decision support.
ANSM
The article provides a general overview of the regulatory requirements for medical devices intended to be marketed and used in France
Medical Devices
Gaining FDA approval is a pivotal milestone for any medical device manufacturer seeking to enter the U.S. market.
Medical Devices
Entering the global medical device market is a complex journey that requires a deep understanding of diverse regulatory landscapes. From the United States to Japan, each country has its own set of rules, timelines, and expectations.
