TÜV Rheinland North America

The EU Medical Device Regulation (MDR) represents a significant overhaul of how medical devices are regulated in Europe. But what does this mean for device manufacturers? MDR key changes: 🔹 Expands definition of medical devices to include certain aesthetic products 🔹 Introduces new classification rules, potentially up-classifying some devices 🔹 Requires more clinical evidence for device approval 🔹 Enhances traceability through Unique Device Identification (UDI) 🔹 Increases post-market surveillance requirements MDR compliance requires: 🔹 Rigorous safety and performance testing 🔹 Comprehensive technical documentation 🔹 Thorough risk management processes 🔹 Detailed post-market surveillance plans Our MDR services include: 🔹 Gap analysis between current status and MDR requirements 🔹 Chemical characterization of device materials 🔹 Biocompatibility testing 🔹 Technical file preparation and review 🔹 Post-market surveillance planning Navigating MDR compliance can be complex, but it's crucial for market access. Let our experts guide you through the process, ensuring your devices meet all necessary requirements ➡ https://lnkd.in/ecxAKmkv #MDR #MedicalDevices #RegulatoryCompliance #PatientSafety #MedTech #TÜVRheinland

📢 ¡Invitación especial a nuestro Webinar! 📢 ¿Estás preparado para las nuevas regulaciones? Únete a nosotros en el webinar "NOM-186 y NOM-051: Lo que Debes Saber Sobre Cacao, Chocolate y Nuevas Regulaciones" y descubre cómo adaptarte a los cambios en etiquetado y normativas. 🗓 Fecha: 12 de noviembre 2024 ⏰ Hora: 15:00 hrs (CDMX) ⏳ Duración: 60 minutos Temas destacados: 🔸 Impacto de la tercera fase de la NOM-051 en la NOM-186 🔸 Diferencias entre denominación genérica y específica 🔸 Declaración de grasas añadidas y sus excepciones 👉 Regístrate aquí y asegura tu lugar: http://tuv.li/1kPB

PFAS is a growing area of concern for regulators and product safety experts worldwide with evolving compliance requirements impacting industries from manufacturing to retail. Staying up to date with these changes can be challenging - but we’ve got you covered! Join us for an in-depth webinar with Geoffrey Bock and Jennifer Barbarisi on Tuesday, October 29th at 2:00 PM EST and gain valuable insights into managing PFAS compliance obligations across the supply chain. Webinar Highlights: 🔹 A clear introduction to PFAS and its risks 🔹 Overview of key regulations in the US, Canada, and the EU 🔹 Practical testing approaches to ensure compliance 🔹 Transparent supply chain practices and due diligence requirements Take advantage of the opportunity to ask questions and learn directly from our experts. Register today and ensure your company stays compliant! https://lnkd.in/ezRGa6jk Lillian Peregrina James Ross Steve Nierenberg Richard Kilroy Sandra Kato Asif Manzur (he/him/his) Michael Cronin Ryan Braman #PFASCompliance #WebinarAlert #IndustryStandards #SustainableBusiness

Are you prepared to navigate the complexities of PFAS compliance? With increasing regulatory focus across multiple industries, staying ahead of the curve is essential for ensuring product safety and avoiding compliance risks. Join us for our upcoming webinar to better understand Per- and Polyfluoroalkyl Substances (PFAS) and their implications across various sectors. This session will give you the knowledge and tools needed to meet today’s regulatory demands, from manufacturing to product safety. 🔷 Date: Tuesday, October 29, 2024 🔷 Time: 2:00 PM EST 🔷 Presenters: Geoffrey Bock & Jennifer Barbarisi What you’ll learn: 🔹What PFAS is and its impact on industry operations 🔹 Global regulatory developments in the US, Canada, and the EU 🔹 Key compliance obligations and supply chain transparency practice 🔹 Testing methods that align with industry requirements Don't miss out - secure your spot now and join us for an insightful session! https://lnkd.in/ezRGa6jk Lillian Peregrina James Ross Steve Nierenberg Ryan Braman Sandra Kato Richard Kilroy Julie Andrews Michael Cronin Asif Manzur (he/him/his) #PFASWebinar #RegulatoryCompliance #ProductSafety #SustainableBusiness #SupplyChainTransparency

In case you missed our recent IEC 61851-21-2 EV compliance webinar with Bruce Fagley or want to access the presentation again, we’ve got you covered!   This session was packed with expert insights on testing, certification, and compliance strategies for AC and DC EV chargers. In addition to a detailed breakdown of IEC 61851-21-2, we discussed:   🔹 Key compliance requirements and how they impact product design 🔹 Testing pitfalls to avoid during certification 🔹 Strategies to optimize your testing process and reduce time-to-market Watch the full webinar here: https://lnkd.in/eNrHESts Steve Nierenberg Geoffrey Bock Ryan Braman Julie Andrews Sandra Kato Richard Kilroy Asif Manzur (he/him/his)   #EVCompliance #ChargingSystems #ElectricVehicle #EVTech #ComplianceExperts #Webinar"

🚨 Important Update for All Importers and Exporters 🚨 Starting January 1st, 2025, any shipment entering the Kingdom of Saudi Arabia will not be cleared unless it is accompanied by both a Product Certificate and a Shipment Certificate, issued through the Saber electronic platform. Do you have questions? Contact our local experts now to ensure your shipments are compliant with the new regulations to avoid delays at customs http://tuv.li/1kMK #TUVRheinland #Regulations #SaberPlatform #Compliance #Import #Export #KSA

California's Proposition 65, officially known as the #SafeDrinkingWater and #ToxicEnforcement Act of 1986, impacts businesses far beyond the Golden State. But what does it mean for your products? #CalProp65 key points: 🔹 Requires warnings for products containing any of 900+ listed chemicals 🔹 Applies to all products sold in California, regardless of origin 🔹 List is updated at least once a year 🔹 Covers a wide range of chemicals, from heavy metals to organic compounds ❗ Did you know? Prop 65 violations can result in penalties of up to $2,500 per day per violation. Prop 65 compliance challenges: 🔹 Keeping up with the constantly updating chemical list 🔹 Determining if your product requires a warning 🔹 Crafting compliant warning language 🔹 Managing supply chain to ensure ongoing compliance Our Prop 65 services: 🔹 Screening for listed chemicals 🔹 Exposure assessments 🔹 Warning label compliance review 🔹 Supply chain documentation management 🚫 Don't risk Prop 65 non-compliance. Our comprehensive testing and consulting services can help you navigate this complex regulation with confidence ▶ #CalProp65 #ProductWarnings #ConsumerSafety #ChemicalCompliance #SupplyChainManagement #TÜVRheinland

TÜV Rheinland's Bodo Seifert is speaking at the Ansys Transportation Summit today, where he'll be discussing automotive functional safety and Safety of the Intended Function as well as automotive cyber security to prevent unexpected behaviors in autonomous vehicles. Learn more about the event: https://lnkd.in/ec6Rr4zw Explore our functional safety and cybersecurity services: http://tuv.li/1kNQ #autonomousvehicles #functionalsafety #cybersecurity

At TÜV Rheinland, we work together to raise awareness about breast cancer. 💖🎗️ Let’s promote early detection, education, and hope for a healthier future for everyone. Every gesture, every conversation, and every action make a difference! Let’s join this cause and support those in need. 💪✨ #PinkOctober #Prevention

Are you looking for a more efficient way to conduct cybersecurity assessments? Introducing TÜV Rheinland's Smart Search Service – an AI-enhanced search function designed to revolutionize your cybersecurity assessment process! 🔍 What is Smart Search? Our cutting-edge Smart Search Service leverages advanced AI technology to streamline the search and analysis process, saving time during the assessment. Don't miss out on the opportunity to enhance your cybersecurity assessment capabilities. 🚀 🌐 Discover More about TÜV Rheinland's services and expertise: http://tuv.li/1kN5 #Cybersecurity #TUVRheinland #SmartSearch #AI #Innovation #ITSecurity #Efficiency