CDSCO releases new draft guidelines aligning India's regulatory framework for medical device software with global standards.
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...
Industry bodies on Wednesday welcomed the draft guidance on medical device software issued by the Central Drugs Standard ...
The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.
Despite the fresh set of guidelines, experts said that technologies like AI are increasingly being used in MedTech sector, ...
The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium has published new consensus recommendations today in The Lancet Regional Health Europe, that set out ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
Imaging Contract Research Organization (iCRO) from Bayer offering tailored services that will span the entire imaging study cycle from concept to completion Supporting early research through Phase IV ...