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Month: November 2024

EU MDR and Clinical Evaluation: Navigating New Expectations for Safety and Performance

We explore the core principles of clinical evaluation under EU MDR, key challenges, and strategies for compliance.

Published November 21, 2024
Categorized as Patrick Gora

Transitioning Legacy Devices to Comply with EU MDR: Key Challenges and Solutions

With careful planning and strategic solutions, manufacturers can navigate this complex process effectively.

Published November 21, 2024
Categorized as Patrick Gora of Rochester

Developing a Comprehensive EU MDR Training Program for Regulatory Compliance Teams

We explore the steps necessary to develop a comprehensive EU MDR training program that empowers teams to meet regulatory demands effectively.

Published November 21, 2024
Categorized as Patrick John Gora

Recent Posts

  • Managing Time Constraints in Medical Device Development: Tips for Staying on Track
  • Creating a Comprehensive Project Plan for Medical Device Development: A Step-by-Step Guide
  • Preparing for Regulatory Audits of Premarket Submissions: Avoiding Common Pitfalls
  • Optimizing Supplier Quality Agreements to Ensure Compliance and Product Safety
  • EU MDR and Clinical Evaluation: Navigating New Expectations for Safety and Performance

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