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