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Creating a Comprehensive Project Plan for Medical Device Development: A Step-by-Step Guide

We outline the key steps and components necessary for creating a comprehensive project plan for medical device development.

Published January 30, 2025
Categorized as Patrick Gora

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

Sterilization Validation in Medical Devices: Meeting Regulatory Standards for Safety

We delve into the importance of sterilization validation, the key methods used, and the regulatory standards that manufacturers must adhere to.

Published October 23, 2024
Categorized as Patrick 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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