Has CDSCO Guidance Changed The Rules? Legal News and Analysis - India - Regulatory & Compliance - Conventus Law ...
Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to roll out despite fears the ...
The court’s rationale Opposition against the IIa classification of telemedicine software Is telemedicine software a medical device at all? Impact on practice and the market Telemedicine is getting ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML evaluation and algorithm change management: CDSCO guidelines ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of ...
The FDA is contemplating changing its medical device for software approval process, JD Supra reports. Here’s what you should know. 1. Software as a medical device applies to all software used to ...
Enlil and Interlynk join forces to transform SBOMs into dynamic tools for managing cybersecurity in medical devices.
On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
The integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When ...
Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...
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