Medical Device & IVD Regulatory | SCIENCE ARENA

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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…

Usability Engineering in Medical Devices: Importance, Regulations, and Documentation

bySCIENCE ARENA -April 10, 2025

Over the past two decades, post-market surveillance has revealed concerning trends of adverse ev…

Quality Management System

Standards and Certification: Identifying Certifiable & Non-Certifiable Standards

bySCIENCE ARENA -March 06, 2025

In today's globalized and highly competitive world, standards play a crucial role in ensurin…

In Vitro diagnostic (IVD)

The Regulatory Landscape and Future Outlook of Microfluidic-Based Diagnostic Devices

bySCIENCE ARENA -March 05, 2025

Microfluidic diagnostic devices, also known as micro flow diagnostic devices, have emerged as a …

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