Medical Device & IVD Regulatory | SCIENCE ARENA

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Quality Management System

When and How the Risk-Based Approach is Applied in Quality Management Systmen Documentation

bySCIENCE ARENA -August 03, 2025

In today’s regulatory landscape—especially in the medical device and life sciences industries—re…

Quality Management System

Bridging Compliance and Performance: Distinct Yet Interlinked Roles of Good Manufacturing Practices and Quality Management Systems

bySCIENCE ARENA -July 14, 2025

In the regulated landscape of manufacturing—particularly in pharmaceuticals, medical devices, an…

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…

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