Sébastien FERRET

EXTEDO at RAPS Euro Convergence 2024 – join our sessions! RAPS Euro Convergence 2024 is where innovation meets collaboration to shape the future of healthcare regulation! Join us on 07 May 2024, as our experts take the stage to share their insights: 🕙 09:50 - 10:50 CEST: "Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions"- featuring Frank Dickert, Senior Business Consultant at EXTEDO. In this presentation, Frank will discuss the benefits of early adoption – increased regulatory efficiency, reduced administrative burden, and a comprehensive view of product lifecycles. You will gain actionable strategies and insights to propel your organization forward! 🕒 15:05 - 16:05 CEST: "From China to WHO: Strategies & Updates to Accelerate China & WHO Drug Approvals and Master Files" featuring Gerhard Neurauter, Vice President Regulatory Competence Center at EXTEDO. Explore the intricacies of eCTD with WHO as Gerhard guides you through the registration process, submission requirements, and the latest Module 1 updates. Discover how to streamline your submission process and overcome implementation challenges with expert guidance and support. You can not attend the sessions and would like to learn more about how EXTEDO can support your organization's regulatory journey? Just reach out to Frank and Gerhard to schedule an individual appointment! #EXTEDO #RAPSEuroConvergence #IDMP #eCTD #WHO

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The path to a sterile product requires validation. When it comes to radiation sterilization, this is regulated by the process standard DIN EN ISO11137. Learn more about the whole process on our website ➡️ https://lnkd.in/evJAP4u #bgs #bgsbetagammaservice #irradiation #qualityassurance

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MDCG published the revised document 'Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746.' This document addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules set out under Annex VIII. Contact us to confirm your device classification. #mdcg #medicaldevices

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📢 𝑪𝒍𝒊𝒏𝒊𝒄𝒂𝒍 𝒆𝒗𝒂𝒍𝒖𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝒐𝒓𝒑𝒉𝒂𝒏 𝒎𝒆𝒅𝒊𝒄𝒂𝒍 𝒅𝒆𝒗𝒊𝒄𝒆𝒔 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟰-𝟭𝟬 June 2024 𝐃𝐄𝐅𝐈𝐍𝐈𝐓𝐈𝐎𝐍: a medical device or an accessory for a medical device should be regarded as ‘orphan device’ if it meets the following criteria: ✔ the device is specifically intended to benefit patients in the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12,000 individuals in the European Union per year ; 𝐀𝐍𝐃 at least one of the following criteria are met: ✔ there is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition, or ✔ the device will offer an option that will provide an expected clinical benefit compared to available alternatives or state of the art for the treatment, diagnosis, or prevention of this disease/condition, taking into account both device and patient population specific factors. Read the document here: https://lnkd.in/eJTezwxn #regulatorycompliance #mdr #ivdr #medicaldevices #devices

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The Need of Symbols in EU MDR Since there are 24 official languages in Europe, there is a need to translate information given on the labels into different languages. By using symbols as an alternative to written languages, these requirements can be met easily. In its Annex I, chapter III, 23.1.h., MDR has permitted the manufacturers to use the symbols in the placement of written languages. There are many benefits of using symbols, such as efficiency and cost reduction. The symbols are also helpful in conveying internationally understood concepts and information to the medical device’s user. Link to complete article https://lnkd.in/eyWPTX-y #tsqe #eumdr #mdr #symbols #medicaldevicelabelling #medical #devices

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