RAPS Western Canada Chapter’s Post

There are only a few days left to register for our upcoming, free IVDR Sprint webinar! If you are going through the Performance Evaluation of your new or legacy IVD device, don't miss the chance to hear from our experts and have your questions answered live. Register now: https://hubs.la/Q02qnWLz0 #IVDR #2024IVDRSprint #PerformanceEvaluation

📰 Public Policy Pulse 👇 ___ 🆕The Q&A on the gradual roll-out of #EUDAMED is now #live! This essential document outlines practical #guidance on implementing the gradual roll-out of EUDAMED, as established under the #MDR and #IVDR frameworks and amended by #Regulation (EU) 2024/1860. It addresses key aspects, including the phased introduction of EUDAMED requirements for notifying interruptions or discontinuations of supply, and transitional provisions for specific in vitro #diagnostic #medical device. Learn more 👉 https://bit.ly/4fEbJ1V ___ 📘 Discover insights into GS1 #Healthcare's contributions to Public Policy here 👉 https://bit.ly/497sX4I #GS1HealthcarePublicPolicyPulse #PatientSafety #GS1Healthcare

Join Alex Laan Head of IVD Notified Body at BSI in this “steps towards IVDR transition” video series, as he walks you through our 23 April webinar on IVDR transition timelines extension. Stay tuned for the upcoming episodes! Register here for the webinar: https://lnkd.in/ec5jHQnm #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar

Join Alex Laan Head of IVD Notified Body at BSI in this “steps towards IVDR transition” video series, as he walks you through our 23 April webinar on IVDR transition timelines extension. Stay tuned for the upcoming episodes! Register here for the webinar: https://lnkd.in/e3vaNZa2 #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar

Join Alex Laan, Head of IVD Notified Body at BSI, in this “steps towards IVDR transition” video series, as he walks you through our 23 April webinar on IVDR transition timelines extension. Stay tuned for the upcoming episodes! Register here for the webinar: https://lnkd.in/eErRikgN #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar

Unlock the potential of Real-World Evidence (RWE) with our latest whitepaper, cowritten with the BSI. In this whitepaper, we explore: - How to integrate RWE into your post-market clinical follow-up (PMCF) activities - How RWE can demonstrate the ongoing safety and effectiveness for your medical device generating the robust data notified bodies require. Challenges and solutions If you’re navigating the complexities of the European Medical Device Regulation (MDR) or aiming to enhance your post-market surveillance strategies, this whitepaper provides the essential knowledge you need. Download today to ensure your products meet the highest safety and performance standards : https://lnkd.in/dQFM4a8s #RWE #RWD #PMCF #MDR #medicaldevices

Join Alex Laan Head of IVD Notified Body at BSI in this “steps towards IVDR transition” video series, as he walks you through our 23 April webinar on IVDR transition timelines extension. Stay tuned for the upcoming episodes! Register here for the webinar: https://lnkd.in/ea7BYYx7 #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar

📢 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗡𝗲𝘄𝘀 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗦𝗲𝗰𝘁𝗼𝗿! 🌏 MDCG has just published the revised version of the 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟯-𝟯 𝗥𝗲𝘃. 𝟭 document, which provides questions and answers on surveillance terms and concepts according to Regulations (EU) 2017/745 (#MDR) and 2017/746 (#IVDR). 👉 𝗣𝘂𝗿𝗽𝗼𝘀𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁: ✅ This document aims to clarify essential terms and concepts described in Section 2 of Chapter VII of the MDR and IVDR Regulations. A common understanding of these terms is crucial for the effective and harmonized implementation of surveillance requirements. 👉 𝗧𝗮𝗿𝗴𝗲𝘁 𝗔𝘂𝗱𝗶𝗲𝗻𝗰𝗲: ✅ Aimed at competent authorities, economic operators and other stakeholders, the document reintroduces Medical Device Surveillance System definitions, adjusted for alignment with the MDR and IVDR. 👉 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲: ✅ The harmonization of terms and concepts is key to ensuring the safety and efficacy of medical devices and in vitro diagnostics, promoting robust and consistent vigilance across the European Union. 🔎 If you would like more details, contact us today to find out more about how 4 Easy PRRC can help you keep up to date with the relevant standards and guidelines: www.4easyprrc.com #MedicalDevices #Surveillance #MDR #IVDR #Regulation #Health #4EasyPRRC #PRRC Celeste Oliveira Natalia de Souza Lescura Viviana Gomes Luiz de Pádua Queiroz Júnior

Join Alex Laan, Head of IVD Notified Body at BSI, in this “steps towards IVDR transition” video series, as he walks you through our 23 April webinar on IVDR transition timelines extension. Stay tuned for the upcoming episodes! Register here for the webinar: https://bit.ly/3Pa0RxC #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar

Join Alex Laan, Head of IVD Notified Body at BSI, in this “steps towards IVDR transition” video series, as he walks you through our 23 April webinar on IVDR transition timelines extension. Stay tuned for the upcoming episodes! Register here for the webinar: https://bit.ly/3Pa0RxC #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar