Medical Device & IVD Regulatory | SCIENCE ARENA

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Quality Management System

From MDD to MDR: How Usability Expectations Evolved — and How Medical Device Manufacturers Can Realistically Meet Them

bySCIENCE ARENA -January 07, 2026

1. Introduction: Usability Was Always There—MDR Just Started Asking the Right Question…

Regulatory Research

Risk-Based Regulation Is Not a Classification Exercise — It’s a Strategic Decision

bySCIENCE ARENA -December 29, 2025

Modern regulations are not written to treat every product, process, or organization the same way…

Regulatory Research

Why Medical Device & IVD PMS / Vigilance Reporting Is Fundamentally Different from Pharmaceutical PMS

bySCIENCE ARENA -December 21, 2025

Medical devices and in vitro diagnostics (IVDs) are regulated globally under frameworks such as …

Regulatory Research

Intended Use and Its Key Elements (Indications, Intended Purpose & Contraindications)

bySCIENCE ARENA -November 17, 2025

In the medical device regulatory ecosystem, “Intended Use” —also referred to as Intended Purpose…

SaMD and SiMD Software Validation: Regulatory Insights into Testing Requirements for Medical Device Software

bySCIENCE ARENA -October 26, 2025

Select Software Type: --Choose-- SaMD (Standalone Software) …

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