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Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Medical Device

USA Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development The guidance provides a framework for determining whether, and what type...

Asia Medical News, EU Regulations, Global Compliance, Healthcare Standards, Medical Device News, Medical Devices, Regulatory Updates, USA Medical Regulations

Consumer Health – USA/UK/Asia/ROW Regulatory News – Oct 2024

November 6, 2024
Consumer Health

USA Outbreak Investigation of E. coli O157:H7: Onions (October 2024) FDA is investigating slivered onions served at McDonald’s as the likely source of this outbreak. Onions have been recalled...

AsiaNews, Consumer Health, Food Safety, Global Health, Health Alerts, Health News, Public Health, Regulatory Updates, UK News, USA News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Biopharma

USA FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer The Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet...

Biotech News, Cancer Treatment, Drug Approval, FDA Approval, Healthcare Updates, Medical Advancements, Medicines, Patient Care, Pharma News, Regulatory News

Utilizing Regulatory Intelligence Software in Risk Management and Compliance

November 5, 2024
Regulatory Intelligence

In today’s fast-evolving business world, corporations face increased pressure to ensure compliance with a nearly ever-changing set of rules and regulations. The range can start from financial...

AI in Compliance, Business Compliance, Compliance Management, Compliance Software, Data Driven Decisions, Operational Efficiency, RegTech Solutions, Regulatory Intelligence, Risk management, Vistaar AI

Key Features to Consider in Regulatory Intelligence Software for 2025

November 4, 2024
Regulatory Intelligence

The regulatory landscape is changing rapidly, and this has been rising challenges for businesses in terms of compliance across different jurisdictions. Tracking, analyzing, and compliance with the...

AI in Compliance, Business Compliance, Compliance Software, Data Driven Compliance, Global Compliance, Machine Learning, RegTech2025, Regulatory Intelligence, Regulatory Updates, Risk management

The Impact of AI on Medical Device Technology and Certification

October 16, 2024
Medical Device

Currently, AI refers to the ability of machines to perform cognitive tasks commonly associated with human intelligence including perception, learning, reasoning, planning, speech and language, and...

AI Algorithms, AI and Data, AI Impact, AI Med Tech, Data Science, Healthcare AI, Healthcare Innovation, Machine Learning, Medical Device Certification, Medical Devices