Skip to content

Patrick Gora Rochester

  • Home
  • Blog

Month: June 2024

Understanding Premarket Approval (PMA) for High-Risk Medical Devices

The PMA process for high-risk medical devices, delving into clinical study requirements, data submission, and the FDA review process.

Published June 24, 2024
Categorized as Patrick Gora of Rochester

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

Recent Comments

No comments to show.

Archives

  • February 2025
  • January 2025
  • November 2024
  • October 2024
  • August 2024
  • July 2024
  • June 2024
  • May 2024

Categories

  • Patrick Gora
  • Patrick Gora of Rochester
  • Patrick John Gora
  • Uncategorized
Patrick Gora Rochester
Proudly powered by WordPress.