Why should stability and performance testing be separate for medical devices? Join ECI for an insightful discussion on Tuesday, October 29th, at 12:00 PM EDT as Laura Vargas Agüero and Gregory Austin explore reasons why, despite long-standing industry practices. ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. Learn how to align with the new standard to ensure compliance and product safety. 📅 Tuesday, October 29, 2024 ⏰ Time: 12:00pm EDT 💡 Interactive Q&A session 👉 Join here: https://lnkd.in/em8_hHhs #medicaldevice #performance #stability #testing
QA/Regulatory/Engineering Consulting Solutions | Medical Device-Biotech-Pharma | Podcaster | Author | Speaker | Cultural Architect | Strategic Encourager
Join Principal Engineering Consultant, Laura Vargas Agüero and me, as we explore why Stability Testing and Performance Testing for medical devices should be conducted separately, despite long-standing industry practices. ISO 11607-1:2019 clarifies that aging tests assess material integrity over time, independent of packaging content or size, while performance testing focuses on how well packaging withstands real-world hazards. We'll dive into the ongoing debate, why some companies haven't changed, and how to align with the new standard to ensure compliance and product safety. #medicaldevice #aging #stability #performance #testing