Tag: EU Regulations

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

June 4, 2025
Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

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

April 8, 2025
Medical Device

USA Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff This guidance document, issued by the FDA, focuses...

EU Regulations, Global Med Tech, Healthcare Compliance, MDR Update, Med Tech News, Medical Device News, Medical Device Regulations, Medical Devices 2025, Regulatory Affairs, Regulatory Update

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 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...

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