As the medical device industry continues to innovate at a rapid pace, ensuring patient safety and regulatory compliance is more critical than ever. Our latest white paper explores the evolving landscape of risk evaluation for gas pathway devices, especially in light of the new ISO 18562 standards.
Why Read This White Paper?
In-Depth Analysis: Discover how the Extractables and Leachables study assesses risks associated with various devices, and understand the significance of particulate matter and volatile organic compounds in patient safety.
Comprehensive Risk Assessment: Learn about the combined risk assessment framework that utilizes both ISO 10993 and ISO 18562, tailored specifically for gas pathway devices.
Real-World Applications: Gain insights into the medical devices that require rigorous safety evaluations, including catheters, ventilators, and more.
Key Topics Covered:
- The importance of biological evaluation for ensuring patient safety.
- Analyzing biological risks based on product categorization, intended clinical use, and patient contact duration.
- Understanding indirect contact medical devices and their implications for patient care.
Stay ahead in the medical device industry by understanding the critical evaluations that ensure the safety and effectiveness of gas pathway devices.