4 Easy PRRC

🚀 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 𝗘𝘅𝗰𝗹𝘂𝘀𝗶𝘃𝗼: Tudo o que precisa de saber sobre #UDI! A Smart MDR convida-o para um webinar essencial sobre a implementação do UDI em dispositivos médicos. Quer compreender os requisitos e garantir a conformidade da sua empresa? Esta é a sua oportunidade de aprender com especialistas experientes na área! 📅 𝗗𝗮𝘁𝗮: 3 de março de 2025 ⏰ 𝗛𝗼𝗿𝗮́𝗿𝗶𝗼: 14h30 (Lisboa - GMT+0) 💻 𝗙𝗼𝗿𝗺𝗮𝘁𝗼: Online 🗣 𝗜𝗱𝗶𝗼𝗺𝗮: Português 🎯 𝗔𝗴𝗲𝗻𝗱𝗮: 🔹 𝟭𝟰:𝟯𝟬𝗵 - Sandra Balseiro - Nomenclatura do UDI 🔹 𝟭𝟰:𝟱𝟬𝗵 - Celeste Oliveira - Emissão do UDI - Contato com as entidades emissoras 🔹 𝟭𝟱:𝟮𝟬𝗵 - Célia Ludovino - Implementação do UDI-PI - Responsabilidades do fabricante 🔹 𝟭𝟱:𝟱𝟬𝗵 - Perguntas & Respostas 👩🏫 𝗣𝗮𝗹𝗲𝘀𝘁𝗿𝗮𝗻𝘁𝗲𝘀: ✅ Sandra Balseiro (Co-Founder - Smart MDR) - Especialista em regulamentação de dispositivos médicos, com mais de 20 anos de experiência e atuação em certificação de produtos MD e IVD. ✅ Celeste Oliveira (Co-Founder - Smart MDR) - Mestre em Regulação de Produtos de Saúde, auditora ISO 13485 e especialista na certificação de dispositivos médicos e IVDs. ✅ Célia Ludovino (Quality Manager - BHL-Medical, Indústria de Produtos Hospitalares, Lda) - Engenheira Química, especialista em Assuntos Regulamentares e certificação CE de Dispositivos Médicos. 📌 Garanta sua vaga e fortaleça seu conhecimento no setor! 🔗 Inscreva-se agora: (https://lnkd.in/d_Z-S8wV) #WEBINAR #UDI #REGULATORYAFFAIRS #MDR #IVDR #REGULATORYCOMPLIANCE #MEDICALDEVICES #IVD #EUREGULATIONS #SMARTMDR

⏳ O prazo para aplicar o UDI aos Dispositivos Médicos de Classe I está a aproximar-se... e o nosso 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 𝗲́ 𝗷𝗮́ 𝗻𝗮 𝗽𝗿𝗼́𝘅𝗶𝗺𝗮 𝘀𝗲𝗴𝘂𝗻𝗱𝗮-𝗳𝗲𝗶𝗿𝗮! 📅 𝗗𝗮𝘁𝗮: 3 de março de 2025 ⏰ 𝗛𝗼𝗿𝗮: 14h30 📍 𝗙𝗼𝗿𝗺𝗮𝘁𝗼: Online Ainda não garantiu a sua inscrição? 𝗔𝗶𝗻𝗱𝗮 𝘃𝗮𝗶 𝗮 𝘁𝗲𝗺𝗽𝗼! 🚀 Este webinar é uma oportunidade única para: ✔️ Compreender os requisitos do 𝗨𝗗𝗜 𝗽𝗮𝗿𝗮 𝗖𝗹𝗮𝘀𝘀𝗲 𝗜 ✔️ Superar desafios na 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝗰̧𝗮̃𝗼 ✔️ Aprender com casos reais de 𝗲𝘀𝗽𝗲𝗰𝗶𝗮𝗹𝗶𝘀𝘁𝗮𝘀 𝗱𝗮 𝗶𝗻𝗱𝘂́𝘀𝘁𝗿𝗶𝗮 🔗 Inscreva-se agora e assegure a conformidade antes do prazo! https://lnkd.in/dUxxHADf Não perca esta oportunidade de estar um passo à frente! #UDICompliance #DispositivosMédicos #RegulamentaçãoMDR #WebinarUDI #SmartMDR

🚀 𝗣𝗿𝗼𝗽𝗼𝘀𝗲𝗱 𝗡𝗲𝘄 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝗼𝗳 𝗜𝗘𝗖 𝟲𝟮𝟯𝟬𝟰: 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝗛𝗲𝗮𝗹𝘁𝗵 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 The second edition of 𝗜𝗘𝗖 𝟲𝟮𝟯𝟬𝟰 is under review and introduces significant changes for medical and health software manufacturers. With an expanded scope, the proposed update now includes Health Software, covering not only medical device software but also other digital health technologies. 🔹 𝗞𝗲𝘆 𝗣𝗿𝗼𝗽𝗼𝘀𝗲𝗱 𝗖𝗵𝗮𝗻𝗴𝗲𝘀: ✔️ Simplified software risk classification (Level I & II) ✔️ Removal of specific Quality System requirements ✔️ More flexibility in Risk Management, no longer requiring ISO 14971 ✔️ Clearer rules for legacy software and maintenance 🌍 𝗛𝗼𝘄 𝗰𝗼𝘂𝗹𝗱 𝘁𝗵𝗶𝘀 𝗶𝗺𝗽𝗮𝗰𝘁 𝘆𝗼𝘂𝗿 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲? Companies may need to adjust their processes to align with the new guidelines once finalized. 📌 𝗦𝗺𝗮𝗿𝘁 𝗠𝗗𝗥 𝗰𝗮𝗻 𝗵𝗲𝗹𝗽! Contact us for support in understanding and preparing for these potential changes. 🔗Read the full proposed IEC 62304 document here: https://lnkd.in/gC59fZDM #IEC62304 #MedicalSoftware #HealthSoftware #Regulation #Compliance #SmartMDR

𝗡𝗲𝘄 𝗘𝗨 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀! 🚀 The regulation of digital health technologies is constantly evolving! A recent study on the EU HTA for digital medical devices (DMDs), including AI, highlights key points for those seeking access to the European market. 🔹𝑨𝒅𝒂𝒑𝒕𝒊𝒗𝒆 𝒂𝒔𝒔𝒆𝒔𝒔𝒎𝒆𝒏𝒕: It is crucial to follow discussions on harmonised assessment to ensure reimbursement and market access. 🔹 𝑬𝒖𝒓𝒐𝒑𝒆𝒂𝒏 𝒉𝒂𝒓𝒎𝒐𝒏𝒊𝒔𝒂𝒕𝒊𝒐𝒏: The EU is moving forward to standardise assessments and overcome differences between countries. 🔹 𝑪𝒉𝒂𝒍𝒍𝒆𝒏𝒈𝒆𝒔 & 𝒐𝒑𝒑𝒐𝒓𝒕𝒖𝒏𝒊𝒕𝒊𝒆𝒔: Current assessments lack focus on AI and adaptation to short life cycles, but there is room for innovation with improved methodologies and real-world evidence. 🔹 𝑨𝒄𝒄𝒆𝒔𝒔 𝒓𝒐𝒖𝒕𝒆𝒔: Countries like Germany (DiGA) and France (PECAN) have already adopted fast-tracks for innovative technologies. 🔹 𝑬𝒗𝒊𝒅𝒆𝒏𝒄𝒆 𝒈𝒆𝒏𝒆𝒓𝒂𝒕𝒊𝒐𝒏: Real-world data and comparative studies are crucial to proving clinical and economic value. 🔹𝑴𝒐𝒓𝒆 𝒕𝒓𝒂𝒏𝒔𝒑𝒂𝒓𝒆𝒏𝒄𝒚: Regulations and evaluation processes for DMDs are clearer in the EU. 📢 Stay up to date and adjust your strategies to ensure your devices have access to the European market. 🔎 Find out more about how Smart MDR can help your company achieve regulatory excellence. 🔗 Access the full file in PDF at: https://lnkd.in/dc_ZECCd #MedicalDevices #HTA #Regulation #DigitalHealth #Innovation #ArtificialIntelligence #EuropeanMarket #MedTech #SmartMDR #4EasyPRRC

🚀 𝗧𝗵𝗲 𝗧𝗵𝗶𝗿𝗱 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝗼𝗳 𝗦𝗺𝗮𝗿𝘁 𝗠𝗗𝗥’𝘀 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿 𝗶𝘀 𝗢𝘂𝘁 𝗡𝗼𝘄! Stay ahead in the ever-evolving world of medical device and IVD regulations with our latest insights and updates. In this edition, we cover: ✅ 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 – Discover its crucial role in ensuring the safety and performance of medical devices. ✅ 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 – Get the latest on MDCG 2019-6 Rev.5, coordinated assessments for clinical investigations, and changes impacting SARS-CoV-2 IVDs. ✅ 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 – Learn about new FDA guidelines and strategies to reduce sepsis transmission risks. ✅ 𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗘𝘃𝗲𝗻𝘁𝘀 – Don’t miss our webinars on UDI implementation and the transition from MDD/AIMDD to MDR. Plus, join us at the 2nd Annual Biocompatibility Testing in Medical Devices Conference! 📩 𝗗𝗼𝗻’𝘁 𝗺𝗶𝘀𝘀 𝗼𝘂𝘁! Click here to read the full newsletter: https://lnkd.in/dq4pJcNJ #MedicalDevices #IVDRegulations #PostMarketSurveillance #SmartMDR #RegulatoryUpdates #MedicalDeviceCompliance #HealthcareInnovation #Newsletter #UDI #MDR #BiocompatibilityTesting #3rdEdition

🔴 É 𝗳𝗮𝗯𝗿𝗶𝗰𝗮𝗻𝘁𝗲 𝗱𝗲 𝗗𝗶𝘀𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗼𝘀 𝗠𝗲́𝗱𝗶𝗰𝗼𝘀 𝗱𝗲 𝗖𝗹𝗮𝘀𝘀𝗲 𝗜? 📅 𝗦𝗮𝗯𝗶𝗮 𝗾𝘂𝗲 𝗼 𝗽𝗿𝗮𝘇𝗼 𝗽𝗮𝗿𝗮 𝗮𝗽𝗹𝗶𝗰𝗮𝗿 𝗼 𝗨𝗗𝗜 𝘁𝗲𝗿𝗺𝗶𝗻𝗮 𝗮 𝟮𝟱 𝗱𝗲 𝗺𝗮𝗶𝗼 𝗱𝗲 𝟮𝟬𝟮𝟱? ⏳ O tempo está a contar! A conformidade com o 𝗜𝗱𝗲𝗻𝘁𝗶𝗳𝗶𝗰𝗮𝗱𝗼𝗿 𝗨𝗗𝗜 𝗱𝗼 𝗗𝗶𝘀𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗼 é essencial para garantir a rastreabilidade, segurança e eficiência dos dispositivos médicos. Para o ajudar a esclarecer dúvidas e garantir a implementação eficaz, a Smart MDR está a organizar um 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 exclusivo: ✅ 𝗗𝗮𝘁𝗮: 3 de março de 2025 ✅ 𝗛𝗼𝗿𝗮: 14h30 ✅ 𝗙𝗼𝗿𝗺𝗮𝘁𝗼: Online 👉 𝗡𝗮̃𝗼 𝗲́ 𝗳𝗮𝗯𝗿𝗶𝗰𝗮𝗻𝘁𝗲 𝗱𝗲 𝗖𝗹𝗮𝘀𝘀𝗲 𝗜? Este webinar também é para si! Descubra boas práticas e expanda os seus conhecimentos na área de dispositivos médicos. 🚀 𝗜𝗻𝘀𝗰𝗿𝗲𝘃𝗮-𝘀𝗲 𝗷𝗮́ 𝗲 𝗮𝘀𝘀𝗲𝗴𝘂𝗿𝗲 𝗼 𝗰𝘂𝗺𝗽𝗿𝗶𝗺𝗲𝗻𝘁𝗼 𝗮𝗻𝘁𝗲𝘀 𝗱𝗼 𝗽𝗿𝗮𝘇𝗼! https://lnkd.in/dUxxHADf 🔗 Não perca esta oportunidade de estar um passo à frente na conformidade regulamentar! #DispositivosMédicos #UDICompliance #UDI #ClasseI #RegulamentaçãoMDR #ConformidadeRegulamentar #DispositivosMédicosClasseI #WebinarUDI #Rastreabilidade #SegurançaEmSaúde #IndústriaMédica #SmartMDR #RegulamentaçãoEuropeia #MarcaçãoCE #SaúdeDigital #InovaçãoEmSaúde

📢 𝗦𝗺𝗮𝗿𝘁 𝗠𝗗𝗥 𝗡𝗲𝘄𝘀𝗹𝗲𝘁𝘁𝗲𝗿 – 𝟮𝗻𝗱 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝗶𝘀 𝗛𝗲𝗿𝗲! Discover the latest trends, insights, and medical device and IVD compliance opportunities. This edition is packed with exclusive content for professionals like you: 🧑⚖️ 𝗘𝘅𝗽𝗲𝗿𝘁 𝗢𝗽𝗶𝗻𝗶𝗼𝗻: The PRRC – Your Key to Compliance in Europe. 📋 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀: Stay ahead with the latest on EMDN and global market developments. 🎓 𝗨𝗽𝗰𝗼𝗺𝗶𝗻𝗴 𝗪𝗲𝗯𝗶𝗻𝗮𝗿𝘀: UDI, ISO 10993-1, MDR technical documentation – all the updates you need! 🌟 𝗢𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀: Join our Expert Network and contribute to exciting projects. 🚀 Don’t miss out on essential updates that can drive your compliance journey forward. 👉 Read the full newsletter here: https://lnkd.in/dWQxc86f #RegulatoryComplianc #EMDN #PRRC #UDI #ISO10993 #MDR #IVDR #GlobalMarketAccess #HealthcareInnovation #SmartMDR #MedTech #RegulatoryUpdates #ExpertNetwork #Newsletter #SecondEdition #Updates #4EasyPRRC

🚀 𝗘𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻: 𝗡𝗲𝘄 𝗥𝘂𝗹𝗲𝘀 𝗳𝗼𝗿 𝗝𝗼𝗶𝗻𝘁 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗘𝗨! The European Commission has introduced 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟮𝟱/𝟭𝟭𝟳, setting a solid framework for joint scientific consultations under the Health Technology Assessment (HTA) Regulation. 𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗶𝘀 𝗺𝗲𝗮𝗻 𝗳𝗼𝗿 𝘆𝗼𝘂?✔️ Clear guidance for health technology developers ✔️ Collaboration with clinical experts, patients, and stakeholders ✔️ Enhanced cooperation with EMA for synchronized consultations These consultations offer a structured platform to align development plans with regulatory requirements, reducing uncertainties, and accelerating pathways to clinical assessments. A big win for innovation and compliance in medical devices and IVDs! 🔗 Explore the full document here: https://lnkd.in/dZkP923M #HTA #MedicalDevices #IVDs #HealthTech #Innovation #EURegulations #Compliance #HTARegulation #TechnologicalInnovation #ScientificConsultations #EURegulations #HealthTechnologyAssessment #EMA #SmartMDR #4EasyPRRC

🔍 𝗦𝘁𝗮𝘆 𝗔𝗵𝗲𝗮𝗱 𝗼𝗳 𝘁𝗵𝗲 𝗖𝘂𝗿𝘃𝗲 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗟𝗮𝘁𝗲𝘀𝘁 𝗘𝗠𝗗𝗡 𝗨𝗽𝗱𝗮𝘁𝗲𝘀! The 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟭-𝟭𝟮 𝗥𝗲𝘃.𝟭 FAQ, updated in January 2025, provides vital insights into the European Medical Device Nomenclature (EMDN). This document outlines the structure, usage, and important updates on how manufacturers should assign codes to their devices in 𝗘𝗨𝗗𝗔𝗠𝗘𝗗. 𝗪𝗵𝘆 𝗶𝘀 𝘁𝗵𝗶𝘀 𝗰𝗿𝘂𝗰𝗶𝗮𝗹? 💡 The 𝗘𝗠𝗗𝗡 is not just a code – it’s a key part of the regulatory puzzle that ensures transparency, efficiency, and accurate device classification within the EU market. With the latest revisions, manufacturers and regulators alike must stay informed to ensure ongoing compliance. 🔗 Ready to dive deeper? Check out the full FAQ here: https://lnkd.in/dYmxE7Xh #MDCG2021 #EMDN #MedicalDevices #EURegulations #EUDAMED #MDR #Compliance #SmartMDR

𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗨𝗽𝗱𝗮𝘁𝗲 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆: 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟱-𝟭 𝗥𝗲𝗹𝗲𝗮𝘀𝗲𝗱!  The Medical Device Coordination Group (MDCG) has published the 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟱-𝟭 document, unveiling the 𝗔𝗱 𝗛𝗼𝗰 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲 𝗙𝗼𝗿𝗺 for updating the 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗡𝗼𝗺𝗲𝗻𝗰𝗹𝗮𝘁𝘂𝗿𝗲 (𝗘𝗠𝗗𝗡). 💡 𝗪𝗵𝗮𝘁’𝘀 𝗻𝗲𝘄 𝗮𝗻𝗱 𝘄𝗵𝘆 𝗶𝘁 𝗺𝗮𝘁𝘁𝗲𝗿𝘀? This document serves as a vital tool for: ✔️ Enabling 𝗡𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗖𝗼𝗺𝗽𝗲𝘁𝗲𝗻𝘁 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘁𝗶𝗲𝘀 (𝗡𝗖𝗔𝘀) and 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝗶𝗲𝘀 (𝗡𝗕𝘀) to propose new codes when existing ones are insufficient. ✔️ Supporting the seamless registration of innovative technologies in the 𝗨𝗗𝗜-𝗗𝗜 𝗺𝗼𝗱𝘂𝗹𝗲 𝗼𝗳 𝗘𝗨𝗗𝗔𝗠𝗘𝗗. ✔️ Providing a clear, structured, and transparent process for submissions. 📌 𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆: While the document is endorsed by the MDCG, it is not legally binding and does not reflect the official position of the European Commission. 👉 𝗗𝗼𝗻’𝘁 𝗺𝗶𝘀𝘀 𝗼𝘂𝘁! For full details and to access the document, click here: https://lnkd.in/dtCd9akH #MedicalDevices #EMDN #UDI #RegulatoryCompliance #SmartMDR #MDCG #EU #RegulatoryAffairs #4EasyPRRC