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Tag: Regulatory Updates

Regulatory Intelligence Database, Software & Tools for Compliance

What is Regulatory Intelligence? Regulatory Intelligence (RI) is the process of collecting, analysing, and interpreting regulatory information to help organizations comply with legal and industry...

Compliance Software, Medical Device Regulations, Pharma Compliance, Reg Tech, Regulatory Affairs, Regulatory Compliance, Regulatory Intelligence, Regulatory Technology, Regulatory Updates

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

USA Guidance on Institutional Review Board (IRB) Written Procedures The FDA and HHS OHRP have jointly issued the final guidance on Institutional Review Board (IRB) Written Procedures to enhance...

Asia Regulations, Europe Regulations, Global Regulatory, Healthcare Regulations, Med Tech Updates, Medical Device News, Medical Devices, Regulatory Updates, ROW Regulatory, USA Regulations

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

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

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