Medical Device & IVD Regulatory | SCIENCE ARENA

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Regulatory Research

ISO 20417:2026 and the Introduction of "Applicable Policy": A New Approach to Medical Device Information Management

bySCIENCE ARENA -June 14, 2026

The publication of ISO 20417:2026, Medical Devices — Information to be Supplied by the Manufactu…

Biocompatibility

Exposure / Contact Duration Categories and Estimation Methodology As per ISO 10993-1

bySCIENCE ARENA -February 22, 2026

Biological evaluation of medical devices is a risk-based process intended to determine the poten…

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 …

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