NAMSA

Most people know NAMSA as a leading biocompatibility lab but did you know we also support medical device packaging validation and testing right here in Irvine? Packaging validation is often one of the most critical and sometimes overlooked components of bringing a device to market. It’s not just about putting a device in a pouch or vial it’s about ensuring the entire packaging system maintains protection and sterility through real-world conditions and over the full shelf life. We support clients across the full packaging lifecycle, including: - Strategy & protocol development aligned to ISO 11607 - Seal strength & integrity testing (ensuring a reliable sterile barrier system) - Distribution / transportation simulation (real-world shipping conditions) - Accelerated and real-time aging studies (supporting shelf-life claims) More importantly, we don’t treat packaging as a silo. We help clients think holistically integrating packaging, sterilization, and biological safety considerations early in development to reduce risk and avoid costly rework later on. Curious, when do you typically start thinking about packaging validation in your development process? #MedicalDevices #MedTech #PackagingValidation #ISO11607 #Sterilization #ProductDevelopment #RegulatoryAffairs

Hello everyone! Are you struggling with gray zones in the revised ISO 10993‑1? NAMSA's upcoming webinar explores practical ways to tackle biological risk estimation, repeated use, and foreseeable misuse. 💡 Key topics: ~ Rethinking "long-term" exposure with non-exposure periods ~ Estimating risk when precise data is missing ~ Managing foreseeable misuse without overcomplicating Join us for real-world scenarios, audience polling, and actionable insights. 📅 Save your spot today! https://lnkd.in/g7k95CQF #MedicalDevices #ISO10993 #Webinar