ECM - Medical Device (Ente Certificazione Macchine)

🚀 Visit us at MEDICA 2024 🚀 Join us from November 11th to 14th in Düsseldorf, Germany, where we will showcase our expertise in certification for medical devices according to MDR 2017/745. Don’t miss the chance to explore opportunities to collaborate! 🔬 📍 Where to find us: Hall 13 / B63 📧 Get in touch with our team Diego Stevanella and Marzia Pellegrini >> https://lnkd.in/dgjgB3GZ #MEDICA2024 #MDR #ECMforMedicalDevice #MedicalDevices #NotifiedBody

🆕 Commission Implementing Decisions published in the Official Journal of the European Union as regards the 𝗵𝗮𝗿𝗺𝗼𝗻𝗶𝘀𝗲𝗱 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 under the medical devices regulations. For MDR ➡️ Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products: https://lnkd.in/e7mZGJaq 📍 Added reference to the standard EN ISO 13408-1:2024. For IVDR ➡️ Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects: https://lnkd.in/dD2bCd2C 📍 Added references to the standards EN ISO 13408-1:2024 and EN ISO 20916:2024. ✔️ Follow us and keep up to date with the latest regulatory news! #HarmonisedStandards #MDR #IVDR #MedicalDevices #OJEU

𝗘𝗖𝗠 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝘆 𝟭𝟮𝟴𝟮 𝗮𝘁 𝗠𝗲𝗱𝗶𝗰𝗮 𝟮𝟬𝟮𝟰! 🗓️ November 11-14, 2024 📍 Dusseldorf, Germany – Hall 13 / B63 We are excited to announce ECM's participation in Medica 2024, the leading international event for the medtech sector. As a Notified Body No. 1282, we are committed to assessing and certifying medical devices in accordance with the EU Medical Device Regulation (MDR). 👉 Join us at 𝗛𝗮𝗹𝗹 𝟭𝟯 / 𝗕𝟲𝟯 to discover more about ECM's certification services and our role as an MDR Notified Body. Meet our team: Diego Stevanella – Sales Manager Medical Devices Division Marzia Pellegrini – Sales Manager & Business Developer We look forward to connecting with manufacturers and professionals from across the medical device industry! 🤝 #MDR #Medica2024 #MedicalDevices #MDRCertification #ECMforMedicalDevices

New MDCG 2024-12 🔍 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams. (October 20214) 💡 This guidance provides instructions and templates for establishing the Corrective and Preventive Action (CAPA) plans, ensuring a structured and efficient approach to address non-compliances identified during joint assessments under the MDR (Article 39) and IVDR (Article 35). 🚀 While the templates are not mandatory, their use will facilitate an efficient, consistent and timely CAPA review process for NBs, DAs and JATs. 🔗 Download the documents: https://lnkd.in/d8EytXtM ◽ MDCG 2024-12 - Guidance: https://lnkd.in/d6-54g_x ◽ MDCG 2024-12 - Annex I (Template CAPA plan): https://lnkd.in/dk_VQpV6 ◽ MDCG 2024-12 - Annex II (JAT review template): https://lnkd.in/dfXw_2PD 🤙 At ECM we are committed to staying up-to-date with the latest regulatory developments and ensuring full alignment with the MDR, providing complete and consistent compliance services for the medical device industry! Contact us for more information on our certification services: Diego Stevanella and Marzia Pellegrini #MedicalDevices #MDCG #MDR #CAPA #ECMforMedicalDevices

11 October 2024 📅 Holy Day of the Saint Patron – Office closure On the occasion of the celebration of the Patron Saint of Valsamoggia, Pope St. Giovanni XXIII, the ECM offices will be closed on Friday 11th October 2024. 📍 Regular activities will resume on Monday 14th October. ✨ Wishing everyone a wonderful celebration! ✨ #Valsamoggia #OfficeClosure #PatronSaintPopeJohnXXIII

UPDATE 📢 "𝙎𝙩𝙪𝙙𝙮 𝙨𝙪𝙥𝙥𝙤𝙧𝙩𝙞𝙣𝙜 𝙩𝙝𝙚 𝙢𝙤𝙣𝙞𝙩𝙤𝙧𝙞𝙣𝙜 𝙤𝙛 𝙖𝙫𝙖𝙞𝙡𝙖𝙗𝙞𝙡𝙞𝙩𝙮 𝙤𝙛 𝙢𝙚𝙙𝙞𝙘𝙖𝙡 𝙙𝙚𝙫𝙞𝙘𝙚𝙨 𝙤𝙣 𝙩𝙝𝙚 𝙀𝙐 𝙢𝙖𝙧𝙠𝙚𝙩" Data from previous surveys of Notified Bodies have been integrated with the responses from the 1st Manufacturers and Authorised Representatives (MF/AR) survey, collected by 31 October 2023. ABOUT THE SURVEY 🔍 The study - started in December 2022 and running for 36 months (December 2025) - has been commissioned by the European Commission, through DG SANTE and the European Health and Digital Executive Agency (HaDEA), in order to: ● Monitor the availability of medical devices in the EU market ● Analyze the impact of medical device and in vitro diagnostic regulations ● Gather insights from key stakeholders such as manufacturers, authorized representatives, and notified bodies. 📝 The updated dashboard (https://lnkd.in/eZmE7urn) offers a detailed and comparable analysis of feedback from stakeholders, ensuring ongoing monitoring of the availability of medical devices in the European Union. 🔗 Download the document "Study supporting the monitoring of the availability of medical devices on the EU market - Study overview and survey results of the 1st MF/AR survey with data status 31 October 2023 (25 September 2024)": https://lnkd.in/edyMq3XB 👉 Stay informed on the latest developments in medical device availability and compliance. Contact us to start your MDR certification journey and ensure your business stays ahead! Diego Stevanella - diego.s@entecerma.it Marzia Pellegrini - marzia.p@entecerma.it #MedicalDevice #EUCompliance #MDR #EUcertification #DGSante

📢 ECM al #RADAY2024! Siamo entusiasti di partecipare al Regulatory Affairs Day 2024, organizzato da Confindustria Dispositivi Medici, il 16 ottobre a Roma! 🔊 Durante la Tavola Rotonda con gli Organismi Notificati, la nostra Technical Manager Vanessa Biavati, condividerà l'esperienza di ECM, focalizzandosi sulle problematiche incontrate durante le attività di certificazione MDR e sulle soluzioni adottate. 💡 Un evento imperdibile per i produttori di dispositivi medici che vogliono restare aggiornati sulle ultime novità normative e potenziare il proprio expertise per affrontare con successo l’iter di certificazione. 👉 Per maggiori informazioni, leggi il nostro ultimo articolo: https://lnkd.in/d8ZWrpmM #DispositiviMedici #MDR #ConfindustriaDM #ECMforMedicalDevices

🌍 WHO releases new 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗯𝗲𝘀𝘁 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗳𝗼𝗿 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 The World Health Organization (𝗪𝗛𝗢) has issued a comprehensive document aiming to strengthen the global coordination and quality of clinical trials and enhance clinical research efficiency. 🔬 Key Objectives: ▪️ Provide high-quality evidence on health interventions ▪️ Minimize research waste ▪️ Provide guidance on sustained clinical trials that are always functional and active for endemic conditions and can pivot in time of emergency or pandemics. 👉 Learn more about best practices for the future of global clinical trials https://lnkd.in/gjtMXmXt #ClinicalTrials #WHO #GlobalHealth #MedicalDevices #HealthSafety

🎉 Exciting news from ECM Medical Device Division! We are proud to announce the issuance of our first MDR certificate under Article 22 of Regulation 2017/745, related to systems and procedure packs! 📄 🔍 Read the full article here: https://lnkd.in/ejVJArPS ✅ ECM continues to lead the way in MDR certification by providing reliable and professional assessment service for medical device manufacturers. 💡 Looking to start your certification journey? Contact our team Diego Stevanella and Marzia Pellegrini to discover how we can help! #MDR #Article22 #ProcedurePacks #MedicalDevice #ECMforMedicalDevices

📅 #RADAY2024 is approaching! Join us on October 16 in Rome to discuss the latest regulatory developments in the medical device sector. Our Technical Manager Vanessa Biavati will share insights on MDR challenges and solutions during the Notified Bodies roundtable. 🔗 Register now: https://lnkd.in/dndVnCsf #MedicalDevices #RegulatoryAffairs #MDR #ConfindustriaDM