Eurofins Medical Device Services US

PFAS are used across the medical device industry due to its lubricity, heat resistance, and durability. Increasingly stringent global regulations and a growing emphasis on sustainability has the industry scrutinizing the role and source of PFAS in medical devices. Today, when PFAS are intentionally incorporated into device components, understanding the quantities, forms, and potential for breakdown or leaching under real-world conditions is critical. But there’s more than meets the eye. PFAS may be lurking in the supply chain of medical devices manufactured without intentional PFAS application. It’s now imperative to assess a device’s supply chain, manufacturing environment, and processing aids as part of a robust risk management strategy. This strategy must include detailed materials traceability and supplier assessments, analytical testing for PFAS contamination, lifecycle assessments of device components, collaboration with current suppliers, and a transition plan for PFAS alternatives. In this webinar, you will learn: - Current and emerging PFAS regulations across the supply chain - Insight into expected and unexpected PFAS sources - How to reduce PFAS through assessing the manufacturing chain

Register for our LIVE Webinar! Ethylene oxide (EO or EtO) remains the cornerstone of medical device sterilization, accounting for approximately 50% of all sterilized devices globally. Despite its unmatched efficacy for heat- and moisture-sensitive products, EO’s classification as a carcinogen and its association with neurological and reproductive risks have prompted decades of scrutiny. As scientific advancements are made, the regulatory landscape changes and we as an industry must evolve as well. As regulatory pressure intensifies, the industry faces a pivotal moment. During this webinar you will learn: - Scientific and regulatory drivers behind EO reassessment - Key challenges in ISO 10993-7 and their practical implications - Changes to ISO 11135 and other regulations designed to reduce EO in sterilization cycles - Eurofins ability to support small scale sterilization needs

Register for our On Demand Webinar: Distribution testing verifies that a medical device or product can be safely transported to the end user and perform as intended in life saving operations. Verifying your tertiary, secondary and primary packaging through distribution testing can mitigate costly design flaws, while providing reproduceable test evidence that can optimize device integrity and packaging material costs. In part one of our package testing webinar series, you will learn how to: - Develop a distribution testing plan that mitigates risk and delays - Conduct testing early on your packaging system to reduce delays and resource loss - Assess similarities and differences of ASTM D4169 & ISTA while providing evidence to support package integrity - Avoid costly delays and mitigate risk for your device to minimize impact to device and patient safety - All registrants will receive an invite to part two in Fall 2025.

Register for our On Demand webinar - Breathe Easy! Significant changes have been introduced with the release of ISO 1856:2024, impacting testing strategies, risk assessments, and even regulatory compliance. Join Eurofins experts to learn critical insights into how these changes impact regulatory strategy and current devices, including regulatory implications for FDA submissions not completed by the July 5, 2026 deadline. During this webinar you will learn: - A comprehensive overview of ISO 18562:2024 testing requirements - Inclusion of personal protective equipment (PPE) within the standard’s expanded scope - New testing requirements, including evaluation of aldehydes and very volatile organic compounds (VVOCs) - The importance of lifecycle management and post-market surveillance - Alignment of ISO 18562-4 with ISO 10993

You’re invited to watch our On Demand webinar with Eurofins PFAS expert, Leonard Harris! During this session, Mr. Harris provides insights into the following: - Current and upcoming PFAS regulations - Risk management - Material alternatives - Supply chain implications - Future insights for device PFAS

Register for our On Demand Webinar Part Two of Eurofins Ophthalmic Webinar Series shifts focus to the benefits of testing programs for intraocular lenses, surgical injectors, contact lenses, and related ophthalmic devices. Join experts Katie Grayson and Rick Camp to hear about actionable data and cutting-edge test methodologies, mitigate ophthalmic device failure risks, and optimize device performance from concept to market. This webinar will share case-based insights and techniques to ensure reliability, safety, and differentiation of your device within today’s competitive market. During this webinar, you will learn how: - Targeted validation testing can expedite time to market - Early testing can reduce redesign and regulatory setbacks - Strategies to ensure device differentiation and performance excellence