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Month: November 2024

The Evolving Role of Real-World Evidence (RWE) in Regulatory Submissions for Medical Devices

In this blog, we discuss how Real-World Evidence is reshaping the regulatory landscape for medical devices.

Published November 21, 2024
Categorized as Patrick Gora of Rochester

Common Reasons for Delays in Regulatory Submissions and How to Overcome Them

Understanding the common reasons for delays and adopting strategies to mitigate them can help organizations streamline their processes and achieve timely approvals.

Published November 21, 2024
Categorized as Patrick Gora

Understanding Combination Products: Regulatory Requirements for Devices with Drug or Biologic Components

A comprehensive overview of combination products, their regulatory requirements, and the pathways to navigate these challenges.

Published November 21, 2024
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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