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Month: July 2024

Mastering the 510(k) Premarket Notification Process: Tips and Insights

An in-depth look at the requirements, submission process, and review timeline for 510(k) submissions.

Published July 23, 2024
Categorized as Patrick John Gora

Understanding Investigational Device Exemptions (IDE) for Medical Device Development

We explore the IDE process, including application requirements, approval procedures, and tips for conducting successful clinical trials.

Published July 23, 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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