📣 News from the FDA: they're aligning their quality system regulations with the International Organization for Standardization (ISO) guidelines. This means a step toward global best practices in manufacturing, ensuring the products you use every day meet the highest standards of quality and safety. Get the full scoop on how this update could affect the diagnostics industry and what it means for IVD products. Click to delve into Ron Shinkman's informative article! 🔗 https://lnkd.in/eu9SvmSz #Healthcare #QualityStandards #FDAUpdates
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Mark your calendars - Sign up for our webinar!!
One week away! Don’t miss MCRA’s IVD Experts James Mullally, Dan Goldstein, and Julie Martel, PhD for our webinar LDT vs. IVD: Adapting to the New FDA Regulations. Join us on Tuesday July 16th at 10am EST, as they discuss the FDA’s final rule on the regulation of Laboratory Developed Tests (LDTs), the timeline for enforcement, key aspects of the rule, and how your organization can align with the new FDA requirements and more. Register here: https://lnkd.in/e8vFVenq #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA
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⭐ ⭐ ⭐ ⭐ Read the latest testimonials to see what previous delegates thought of the course Fundamentals of the EU IVD Regulation (IVDR) which is due to run again this October 14. #educolifesciences #ivdr #medicaldeviceregulations #regulatorytraining
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On January 23, the European Commission published on its website a Questions and Answers document on EUDAMED required to explain the implications of the new EU Regulation 2017/746 (IVDR) on the European IVD market. The various points of the document explain what will happen in the near future during the transition period from the old directive to the new IVD regulation in addition to explaining the central importance of EUDAMED. Source: https://lnkd.in/dmhGVZck #ivd #ivdd #ivdr #EUDAMED #qualityassurance #regulatoryaffairs #vlfconsulting
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MCRA's IVD + LDT teams have been closely monitoring the #FDA Final Rule regarding Laboratory Developed Tests. Our former FDA IVD regulators have shared several key insights. We know this new rule may impact your operations. Schedule a free consultation call to learn how MCRA’s experts can help your business adapt to this change. https://lnkd.in/dkzfE-Tf #IVD #LDT #LDTrequirements #LDTrule #FDA #FDAexperts #FDArules #FDAconsultants #IVDregulatory #regulatory #regulatoryaffairs #LDTregulations #FDAregulations #freeconsult #FDAapproval
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Why not access our cost effective digital disruptor solution? Find efficiences for your IVD clinical trial strategies to get your device on market sooner to benefit the patient. Make an impact. #ARC360 #ClinicalTrials
📈 Accelerate your CDx Clinical Performance Study applications with ARC360 📈 Feeling the pain when trying to find the latest requirements for conducting IVD or CDx studies in France or China? The ARC360(R) Regulatory Navigator provides you with up-to-date regulatory intelligence for 40+ countries worldwide. Confidence starts here. ARC360® details the requirements for both Central Testing Laboratories and Sample Collection Sites, including: 💡Regulatory Authority Notification/Authorisation 💡Ethics Committee submission 💡Safety Reporting 💡Latest information and real-world experiences Learn more about how you can enjoy the ARC360(R) digital regulatory consultant by clicking here ➡️https://bit.ly/3Tvhu8o Alternatively, book a demo now ➡️ https://bit.ly/4aoClkz
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Read our latest blog from Karin A. Hughes, Ph.D., SVP Global Regulatory and Quality, on the EU Commissions January 24th posted proposal for a further extension to apply the IVDR under certain conditions – and what this means for IVD manufacturers with products currently in the EU market and those in development. Read blog: https://lnkd.in/eGwUKg4N #IVDR #EUCommission #regulatoryaffairs
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Reach out to our team to understand the implications of this new rule for your business and get the support you need through the transition. We are here to help!
MCRA's IVD + LDT teams have been closely monitoring the #FDA Final Rule regarding Laboratory Developed Tests. Our former FDA IVD regulators have shared several key insights. We know this new rule may impact your operations. Schedule a free consultation call to learn how MCRA’s experts can help your business adapt to this change. https://lnkd.in/dkzfE-Tf #IVD #LDT #LDTrequirements #LDTrule #FDA #FDAexperts #FDArules #FDAconsultants #IVDregulatory #regulatory #regulatoryaffairs #LDTregulations #FDAregulations #freeconsult #FDAapproval
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PN Update: This Week at FDA: Updated guidance on denying inspections and biosimilar interchangeability
This Week at FDA: Updated guidance on denying inspections and biosimilar interchangeability
raps.org
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🚀 a big shout out to all of my Life & Health Sciences friends, associates, colleagues, peers & connections. I’ve recently joined the awesome ARC Regulatory team, we’re on a mission to build & scale ARC360 “Digital Regulatory Solution” for our global customers & partners, please take a moment to learn more about ARC360! 🚀#ARC360 #SaaS #Clinical #Regulatory #IVD #CDx
📈 Accelerate your CDx Clinical Performance Study applications with ARC360 📈 Feeling the pain when trying to find the latest requirements for conducting IVD or CDx studies in France or China? The ARC360(R) Regulatory Navigator provides you with up-to-date regulatory intelligence for 40+ countries worldwide. Confidence starts here. ARC360® details the requirements for both Central Testing Laboratories and Sample Collection Sites, including: 💡Regulatory Authority Notification/Authorisation 💡Ethics Committee submission 💡Safety Reporting 💡Latest information and real-world experiences Learn more about how you can enjoy the ARC360(R) digital regulatory consultant by clicking here ➡️https://bit.ly/3Tvhu8o Alternatively, book a demo now ➡️ https://bit.ly/4aoClkz
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#RegUpdatesWithRegDesk From January 1, 2024, the medical equipment registration process in Israel, including Class I (I, Is, Im, Ir) and low-risk IVD laboratory equipment, has shifted to a self-declaration route by shareholders and importers. Registration holders or importers must attach a signed declaration (no need for an attorney's signature). This registration applies only to medical equipment registered and marketed in recognized countries. The declaration route ensures immediate confirmation via the vaults portal. The registration holder or importer is responsible for independently transferring applications in the normal route and awaiting review in the normal route to the declaration route. Follow: 👉 RegDesk and get daily regulatory alerts sent straight to your inbox. Get Started: 👉 https://lnkd.in/gxfStEAv #MedicalDevices #ivd #registeration #declaration route #regulatoryaffairs #import #amar #israel #2024
