Resilience’s Post

When discussing process validation, we are referring to routine monitoring of the sterilization process performance. The aim of the routine monitoring is to allow validation of the sterilization process (meaning performing sterilization to STAATT IV). Additionally, when conducted in parallel with parametric monitoring (temperature, time and concentration of the active substance), it aims to re-validate the parameters values at which the sterilization process was initially validated. The Envomed Self Validation Kit makes this process straightforward and efficient. Want to learn how it works? Let us show you! #envomed

In May 2024, the US FDA decided it was time to put laboratory developed tests in the medical devices club, shaking things up in the world of diagnostic testing and redefining what in-vitro diagnostic devices really are. This shake-up is all about making tests better, which translates to improved safety and care for patients. Our white paper breaks down the new do's and don'ts facing laboratories, packed with tips to help you navigate this new adventure. Grab your copy today and get ready to ace the compliance game. #LDTs #laboratories #FDA

The FDA’s new regulatory framework for Laboratory Developed Tests (LDTs) underscores the importance of a robust regulatory, quality and compliance program. ELIQUENT Life Sciences serves as a trusted partner to companies preparing to comply with FDA's new LDT requirements. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists guide LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape. Learn more about our tailored solutions at https://lnkd.in/eqF8ijVN

Navigating the #FDA’s new #LDT regulations requires the expert insight and technical skill of a trusted regulatory partner. ELIQUENT Life Sciences' highly skilled team partners with companies to ensure seamless compliance and a forward-thinking approach to the evolving regulatory landscape. Learn more about ELIQUENT's LDT solutions at https://lnkd.in/eqF8ijVN

📝 Did you catch this blog post on Oral Fluid Testing? We’re diving deep into how oral fluid testing is revolutionizing drug testing with enhanced accuracy and unmatched convenience, making it easier for you to stay compliant and efficient! Check out our insights to see how this innovative method can benefit your organization and improve your testing processes. It’s a game-changer that could redefine your approach to workplace safety and regulatory compliance! 📚 https://loom.ly/BXHR43Q #BlogHighlight #OralFluidTesting #DrugTestingInsights

Deadlines to comply with #FDA's new #LDT framework are quickly approaching...ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation. The firm's new LDT service offering, backed by a team of best-in-class experts, guides companies to a smooth and successful adoption of the new regulatory requirements. Learn more about ELIQUENT's LDT solutions at https://lnkd.in/eqF8ijVN

Deadlines to comply with #FDA's new #LDT framework are quickly approaching...ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation. The firm's new LDT service offering, backed by a team of best-in-class experts, guides companies to a smooth and successful adoption of the new regulatory requirements. Learn more about ELIQUENT's LDT solutions at https://lnkd.in/eqF8ijVN

A successful transition to the #FDA's new #LDT regulations is critical for laboratories and companies operating in this space. ELIQUENT Life Sciences' new LDT service offering, backed by ELIQUENT's unprecedented assembly of regulatory leaders, industry experts, and technical specialists, guides companies to a smooth and successful adoption of the new regulatory framework. Learn more about ELIQUENT's LDT solutions at https://lnkd.in/eqF8ijVN

Is your company ready for the #FDA's new #LDT framework? ELIQUENT Life Sciences is uniquely positioned to support organizations during this critical transformation. With expert guidance from our experienced team, your organization can confidently navigate the new framework while ensuring compliance and staying competitive in this dynamic regulatory environment. Learn more about ELIQUENT's LDT solutions at https://lnkd.in/eqF8ijVN

🚨 Important Update on Novel EO Sterilization Validation Approach 🚨 To medical device manufacturers dealing with EO sterilization: Today, we bring to your attention a video that critically examines the novel approach to EO sterilization validation which is 😌 instead of demonstrating the SAL based on a meaningful and reliable kill rate at the most challenging location of the device 😧 rather relying on product tests of sterility without calculating a meaningful kill rate.   Our discussion, backed by experts from industry and regulatory bodies, highlights concerns about its statistical reliability, potentially impacting regulatory acceptance and the sterility of medical devices. Key Points: ☝Regulatory Challenges: Why this method might not be accepted by regulatory bodies. ☝Risk of Unsterility: The potential increase in unsterile products if adopted globally.   👀 Watch the embedded video below to understand the implications and join the conversation. We encourage you to watch the entire video, but if you're short on time and just want an insight, please skip ahead to minute 20:15. Your perspective is critical to shaping future standards. Let’s ensure our practices safeguard patient health and comply with regulatory expectations. Many thanks in advance for an engaging conversation! SteriComp GmbH   https://lnkd.in/eXzwtXj3   #MedicalDevices #Sterilization #EOsterilization #ISO11135 #ISO #HealthcareSafety [1] ISO/DIS 11135.2:2023 (https://lnkd.in/eC4ggzFF), i.a. Annex B4. [2] Fundamentals of Sustainable EO® Sterilization at #steris website or https://lnkd.in/e6SPE8-H