Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage, or handling. Many device regulators require medical device shelf-life and package testing to the ISO 11607 series of standards to ensure devices remain sterile until the barrier system is opened. In this free webinar, Marcus Corzilius, Global Service Line Leader - Medical Device Testing for UL will outline how to comply with requirements in EN ISO 11607, including:
• A review of related general safety and performance requirements (MDR)
• Key terms and definitions
• Considerations to packaging system design
• Test methods overview
• Packaging process validation
• Shelf-life study design
• And much more…
ABOUT THE PRESENTER
Marcus Corzilius is Global Service Line Leader - Medical Device Testing at UL’s office in Ochsenhausen, Germany. He previously served as Engineering Manager for UL’s European Medical Electrical Equipment safety testing team, and his areas of expertise include conformity assessment, testing laboratory operations, and process improvement.
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