Medical Device & IVD Regulatory | SCIENCE ARENA

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DTAB 92nd Meeting Update: No Loan License Needed for Device Sterilization – Know the New Rule

bySCIENCE ARENA -June 25, 2025

India’s medical device industry is rapidly evolving, and regulatory reforms continue to shape a …

Regulatory Research

Medical Device Assessment and Approval Methods – A Study

bySCIENCE ARENA -May 11, 2025

Objective: This study compares regulatory assessment and approval methods for medical devic…

Quality Management System

Risk Priority Number (RPN): A Practical Guide to Risk Assessment in Quality and Safety Systems

bySCIENCE ARENA -April 30, 2025

Risk management in medical devices is a structured process that identifies, assesses, and contro…

Quality Management System

Choosing Product Development Methodologies in Regulated Industries: Waterfall vs. Agile

bySCIENCE ARENA -April 15, 2025

Industries like medical devices, in vitro diagnostics (IVDs), pharmaceuticals, and biotechnology…

FDA Regulatory Pathways for LNP(Lipid Nano Particle)-Based mRNA Therapeutics: Fast Track to Approval

bySCIENCE ARENA -April 11, 2025

Messenger RNA (mRNA)-based therapeutics have ushered in a new era of precision medicine. These t…

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