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.
Australia
The document provides an overview of the applicable regulatory requirements in the sphere of unique device identification.
