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Month: February 2025

Challenges of Conducting Clinical Investigations for Medical Devices Under EU MDR

While compliance with MDR is demanding, it ultimately benefits patients by ensuring that medical devices meet the highest safety and performance standards.

Published February 28, 2025
Categorized as Patrick Gora of Rochester

How AI is Changing the Future of Pharmacovigilance: Regulatory Implications

We explore the impact of AI on pharmacovigilance, the benefits it offers, and the regulatory implications that accompany its adoption.

Published February 28, 2025
Categorized as Patrick John Gora

The Role of Companion Diagnostics in Precision Medicine: Regulatory Challenges and Market Trends

CDx development and approval face significant regulatory hurdles, and the market dynamics for these diagnostics continue to evolve.

Published February 28, 2025
Categorized as Patrick John Gora

Recent Posts

  • Challenges of Conducting Clinical Investigations for Medical Devices Under EU MDR
  • How AI is Changing the Future of Pharmacovigilance: Regulatory Implications
  • The Role of Companion Diagnostics in Precision Medicine: Regulatory Challenges and Market Trends
  • Essential Components of a Strong Regulatory Dossier for Medical Devices
  • How to Manage Regulatory and Quality Risks in Medical Device Projects

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