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