Medical Device & IVD Regulatory | SCIENCE ARENA

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Regulatory Research

Design & Technology Transfer Agreement – Template with Guidance

bySCIENCE ARENA -August 17, 2025

A Design Transfer Agreement (DTA) is a formal contract between a Licensor (technology owner) an…

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…

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