Medical Devices
This article provides a detailed overview of the M11 draft which covers how clinical trial protocols are created, shared, and reviewed.
RegDesk News/Info
Artificial Intelligence (AI) is no longer emerging in healthcare, it’s here and it’s changing everything. From revolutionizing diagnostics to enabling real-time patient monitoring, AI is accelerating innovation across the MedTech landscape.
European Union
The article describes the approach followed by the Turkish regulating authorities in the course of harmonisation of the national legislation in the sphere of medical devices with the relevant European regulations.
RegDesk News/Info
The medical device industry is experiencing rapid growth and innovation. However, this process brings with it an increasing number of regulatory requirements that vary across regions and are subject to frequent changes.
CBER
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
RegDesk News/Info
In today’s medical device industry, innovation alone isn’t enough. To succeed globally, companies must also navigate a maze of regulations that vary across different markets.
