Richard Vincins

💥26th May 2024 is the first important deadline for MDR transition 💥 If you manufacture legacy devices and want to continue under MDR, you only have FIVE DAYS to meet the first standards for your MDR transition. 🔴BY 26 MAY 2024🔴 - Your QMS must be MDR compliant. - You must send a written assessment application to a Notified Body. 🔴BY 26 SEPTEMBER 2024🔴 - Your MDR Agreement must be signed with the Notified Body. 💥Your MDD/AIMDD certificates will no longer be valid if your medical devices don't meet the MDR standards by the 26 MAY 2024💥

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💥26th May 2024 is the first important deadline for MDR transition 💥 If you manufacture legacy devices and want to continue under MDR, you only have NINE DAYS to meet the first standards for your MDR transition. 🔴BY 26 MAY 2024🔴 - Your QMS must be MDR compliant. - You must send a written assessment application to a Notified Body. 🔴BY 26 SEPTEMBER 2024🔴 - Your MDR Agreement must be signed with the Notified Body. ❇️MDCG 2020-6 provides MDD legacy devices with an easier route to get MDR CE marking❇️ 💥Your MDD/AIMDD certificates will no longer be valid if your medical devices don't meet the MDR standards by the 26 MAY 2024!💥

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💥26th May 2024 is the first important deadline for MDR transition 💥 If you manufacture legacy devices and want to continue under MDR, you only have FOUR DAYS to meet the first standards for your MDR transition. 🔴BY 26 MAY 2024🔴 - Your QMS must be MDR compliant. - You must send a written assessment application to a Notified Body. 🔴BY 26 SEPTEMBER 2024🔴 - Your MDR Agreement must be signed with the Notified Body. MDCG 2020-6 greatly reduces the amount of clinical data you need to obtain MDR CE. Devices that lose their MDD Article 120 extension will be required to do extensive Clinical Investigations to obtain MDR CE marking!! ⏱️Make sure you beat the deadline⏱️

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MDCG 2021-25 Rev.1 Guidance Document This document outlines the application of MDR requirements to legacy devices and those placed on the market before May 26, 2021. It provides clarity on how manufacturers should comply with the updated regulations for these devices, ensuring ongoing safety and performance in the market. This guidance is essential for anyone involved in managing legacy devices within the medical device landscape. #MDCG #MDR #MedicalDevice #LegacyDevices #MedicalConsulting

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42Q Ensuring Quality and Compliance in Medical Manufacturing 42Q's advanced MES capabilities are transforming how medical devices are produced, providing comprehensive solutions for: -Complete Traceability: Track product and component genealogy at a granular level, building complete traceability trees for enhanced quality control and audit readiness. -Regulatory Compliance: Effortlessly maintain compliance with industry standards like 21 CFR Part 11, EU MDR, and ISO 13485. -GxP Ready: Our system is designed, validated, and maintained in accordance with GxP requirements, ensuring the highest levels of quality and safety. -Operator Training Integration: Seamlessly integrate with systems that track operator training and certification, guaranteeing a skilled and qualified workforce. Learn how 42Q empowers medical device manufacturers to deliver innovative and compliant products: https://lnkd.in/esscP-mj #42Q #MedicalDevices #MedTech #Manufacturing #MES #DigitalHealth #Compliance #Traceability

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✨Join us for a live webinar exploring the many opportunities within Quality Assurance for MedTech Professionals, hosted by industry experts from Key2Compliance✨ Whether you are just starting out or looking for mid-career progression, this webinar will equip you with practical strategies and actionable steps to support a successful career in MedTech Quality Assurance. You’ll have a chance to hear and discuss with a panel of experts actively working in the field as they share best practices for gaining valuable experience to support advancement in MedTech QA. ◾ What’s hot in the industry right now: We’ll discuss the areas and skills that are most in demand by employers and explore how technology is changing the game. ◾ Expert Insights: Hear from seasoned professionals as they share their unique career journeys and real-world experiences working as consultants and trainers in the Nordic region ◾ Develop Your Career Plan: Empower yourself with the tools and knowledge needed to craft your own career plan within the realm of QA. Discover the courses and certifications that can help you stand out. ◾ Interactive Q&A Session: Don’t miss the chance to engage directly with our panelists during the session! Ask questions, seek advice and make connections. Register now and take your next step to unlock your full potential in this exciting field 🚀👇🏻 https://lnkd.in/gX2fvnQ7 📅 Date: 28th of May 🕒 Time: 13:00-13:30

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💥26th May 2024 is the first important deadline for MDR transition 💥 If you manufacture legacy devices and want to continue under MDR, you only have ONE MORE DAY to make sure your MDR transition project goes ahead. 🔴BY 26 MAY 2024🔴 - Your QMS must be MDR compliant. - You must send a written assessment application to a Notified Body. 🔴BY 26 SEPTEMBER 2024🔴 - Your MDR Agreement must be signed with the Notified Body. Don't lose the MDD Legacy device route to obtain MDR CE marking. 💥Your MDD/AIMDD certificates will no longer be valid if your medical devices don't meet the MDR standards!💥

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🔧 Revised and Refined: Essential Insights into Functional Safety for Medical Devices! We've just reworked our blog article, going back to the roots of safety in medical devices. Explore the key concepts of functional and passive safety, understand the latest standards, and see how the industry is evolving. From foundational concepts to the changing safety landscape, this go-to read is your key to grasping the critical elements of functional safety. 🔗 https://lnkd.in/d8AMq9df #MedicalDevices #FunctionalSafety #SafetyFirst

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🚨 Claiming Equivalence under EU MDR can be a tempting option for manufacturers looking to save both time and money when getting their medical devices certified with the CE mark. However, recent tragedies involving devices like breast implants and hip replacements have highlighted the importance of caution in rushing through equivalency submissions. 🔬 Skipping clinical studies means removing a crucial safety reassurance from the registration process, potentially putting patients at risk. To address these concerns and ensure the quality and safety of medical devices in the EU, the Medical Device Regulation (MDR) came into effect in May 2021. This new legislation mandates CE marking for all products and has updated the certification process to prioritize patient safety. By claiming equivalence with another device that meets certain criteria outlined in clinical evaluation requirements, manufacturers can bypass conducting expensive and time-consuming clinical studies while still meeting safety standards under the MDR. 💡 The key lies in demonstrating that their device is technically, biologically, and clinically equivalent to an existing device used in similar situations by identical users – thereby ensuring similar expected patient outcomes. To learn more about the requirements for claiming equivalence under the EU Medical Device Regulation (MDR) 👉👉 visit https://lnkd.in/egGFT2Mv #EUmdr #medicaldevices #equivalency #safetymatters #MDR #CEmarking #EquivalenceUnderMDR #MedicalDeviceCertification #ClinR #CLINrPlus #medicaldevicesafety #equivalence

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🌟 MDCG 2019-13 Rev. 1 Guidance Simplified 🌟 We are excited to share insights into the latest guidance document that outlines essential criteria for sampling and reviewing the technical documentation of MDR Class IIa/IIb and IVDR Class B/C devices. Key highlights include: Representative device sampling before certification to ensure compliance. Annual surveillance and post-market assessments focused on safety and performance. A rigorous review of documentation in line with Annex I-III requirements. Dynamic sampling plans that adapt to evolving product portfolios and compliance needs. Understanding these criteria is vital for manufacturers to navigate regulatory requirements effectively and maintain high safety standards. Stay informed and enhance your compliance strategy! #MDCG #MedicalDevices #MDR #IVDR #RegulatoryCompliance #QualityAssurance #TechnicalDocumentation #DeviceSafety

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Struggling to create MDR-compliant technical documentation for your Medical Device Software? We’ve reached the final session of our 5-part webinar series, and you won’t want to miss it! This Thursday, Caroline will guide you through interpreting MDR requirements, choosing the right accredited Notified Body, and understanding the qualification and classification process—all with your software’s Intended Purpose in mind. 🔍 Get the practical insights you need to craft essential technical documentation with confidence. 👉 Register today: https://hubs.li/Q02V3NRT0 #MDSW #MDR #MedicalDeviceSoftware #TechnicalDocumentation

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Why is Design for Manufacturing (DFM) often an afterthought in medical device development? It comes down to early-stage priorities. In the rush to innovate and meet strict regulatory demands, teams are focused on one thing: creating a clinically effective, compliant product. Manufacturing? It’s left for “later.” Here’s why DFM should be a priority from the start - → 𝐂𝐨𝐬𝐭 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 By factoring in manufacturing feasibility early, teams avoid expensive reworks, material waste, and blown-out budgets. → 𝐒𝐜𝐚𝐥𝐚𝐛𝐢𝐥𝐢𝐭𝐲 If a design isn’t built for mass production, demand spikes can quickly turn into manufacturing headaches. → 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 Adjustments to accommodate manufacturing at the eleventh hour often trigger additional regulatory reviews, delaying product launch. → 𝐑𝐞𝐥𝐢𝐚𝐛𝐢𝐥𝐢𝐭𝐲 Inconsistent manufacturing impacts product quality and patient safety. DFM mitigates risks, setting up for reliable, high-quality production. Follow for more.

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𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗨𝗽𝗱𝗮𝘁𝗲𝘀: 𝗪𝗵𝗮𝘁 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗡𝗲𝗲𝗱 𝘁𝗼 𝗞𝗻𝗼𝘄 𝗳𝗼𝗿 𝟮𝟬𝟮𝟱 𝗮𝗻𝗱 𝗕𝗲𝘆𝗼𝗻𝗱 𝗣𝗼𝗱𝗰𝗮𝘀𝘁 In this episode of the Global Medical Device Podcast, Etienne Nichols 🎙️ sits down with Leonard (Leo) Eisner, founder of Eisner Safety Consultants - a leading voice in #IEC60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed., focusing on the rationale behind these changes, their impact on medical device design, & how MedTech professionals can prepare for the future.

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What do sterile services departments need to know about the UK Medical Devices Regulations? Jack Walters provides an insight into the ‘UK MDR for Healthcare Organisations’ and discusses how this applies to the reprocessing of surgical instruments.

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#DTAC and its components are updated over time. This requires an ongoing commitment to quality and safety throughout your product’s lifetime. 📶 Your #healthtech has to prove continuous conformance even as rules change. ❌And outdated regulations can trip you up during the critical tendering process. 🤝The #NHS isn’t interested in one-off compliance. And neither are we... That’s why we automated compliance for healthtech #innovators like you. The DTAC Squirrel™ will help you make sense of the entire process: It will gather evidence, and ensure #compliance– all in real-time, all on its own. https://zurl.co/Ufq7 #regulatorycompliance #marketaccess #digitalhealthsolutions

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By 26 May 2024 manufacturers transitioning legacy devices to the MDR have to put in place an MDR compliant QMS and formally apply to a Notified Body. Be aware that at the time of application, you need to provide the documentation required as per the applicable Annex (e.g., Annex IX, clause 2.1). #BSI #MedicalDevices #MDRTransition

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Did you catch the Design For Manufacturability (DFM) Q&A between MRPC and Medical Product Outsourcing? If not, give it a read. Jeff Randall, PE, MRPC's Vice President and Sean Fenske, Editor-in-Chief at MPO discuss when DFM should take place in the medical device manufacturing process, "tools" involved, and how to properly leverage external resources to properly implement DFM. https://lnkd.in/gTdtxZs7 #medicaldevices #medicaldevicemanufacturing #medicalmanufacturing #designformanufacturability #medicalcomponents #medicalinnovation

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