Here are some strategies for navigating time constraints while maintaining quality, compliance, and innovation in medical device development.
Category: Patrick John Gora
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.
EU MDR Technical Documentation: Best Practices for Compiling and Maintaining Compliance
We explore best practices for compiling and maintaining EU MDR technical documentation.
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.
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.
Comparative Analysis of Regulatory Submission Pathways: 510(k) vs. PMA vs. EU MDR
A comparative analysis of regulatory submission pathways for medical devices, with submission requirements and strategic considerations.
The Role of Remediation in Medical Device Quality Systems: Ensuring Compliance and Enhancing Product Quality
We explore how medical device companies can effectively manage remediation activities to improve product quality.