Tag: Global Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

Medical Device Regulatory Challenges & Solutions | Expert Insights

September 13, 2024
Medical Device

Medical devices must meet stringent regulatory requirements to ensure safety and efficacy. These regulations are crucial but can also be complex and challenging for companies. Understanding and addressing...

Compliance Services, Device Compliance, Global Regulations, Medical Device Regulation, Regulatory Challenges, Regulatory Experts, Regulatory Solutions, Regulatory Strategy, Regulatory Updates

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

April 8, 2024
Biopharma

USA Three FDA Final Guidance’s on Electronic Submission of Safety Reports Three FDA final guidance’s address electronic submissions for reporting adverse reactions — one for investigational...

BioPharma Industry, Global Regulations, Industry News, Pharma Insights, Regulatory Updates