Nicolas Chardon

- Challenges of Competency for AI-Notified Bodies For full episode check: https://lnkd.in/eh_fiKfZ Monir El Azzouzi Erik Vollebregt #easymedicaldevice #medicaldevice #regulatorycompliance

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𝐀𝐭 𝐙𝐞𝐧𝐭𝐢𝐬 𝐌𝐞𝐝𝐢𝐜𝐚𝐥, 𝐰𝐞'𝐯𝐞 𝐥𝐞𝐚𝐫𝐧𝐞𝐝 𝐭𝐡𝐚𝐭 𝐜𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐚𝐫𝐞 𝐣𝐮𝐬𝐭 𝐨𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐢𝐧 𝐝𝐢𝐬𝐠𝐮𝐢𝐬𝐞. 𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐬𝐨𝐦𝐞 𝐥𝐞𝐬𝐬𝐨𝐧𝐬 𝐰𝐞'𝐯𝐞 𝐩𝐢𝐜𝐤𝐞𝐝 𝐮𝐩 𝐚𝐥𝐨𝐧𝐠 𝐭𝐡𝐞 𝐰𝐚𝐲: 1. 𝐄𝐦𝐛𝐫𝐚𝐜𝐞 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧: Working together is key. At Zentis Medical, we bring people with different skills and ideas together to make our projects even better. This means our software is more creative and solves problems more effectively. 2. 𝐏𝐫𝐢𝐨𝐫𝐢𝐭𝐢𝐳𝐞 𝐟𝐥𝐞𝐱𝐢𝐛𝐢𝐥𝐢𝐭𝐲: Things change fast in our industry, so we have to be ready to change too. We use flexible methods that let us adapt quickly to new ideas and feedback. This means our software stays up-to-date and can handle whatever comes its way. 3. 𝐅𝐨𝐜𝐮𝐬 𝐨𝐧 𝐪𝐮𝐚𝐥𝐢𝐭𝐲: Quality is super important. We test our software rigorously to make sure it's safe and reliable. This means our clients can trust that our software will work well every time. 4. 𝐍𝐞𝐯𝐞𝐫 𝐬𝐭𝐨𝐩 𝐥𝐞𝐚𝐫𝐧𝐢𝐧𝐠: We're always learning new things. In our industry, technology moves fast, so we have to keep up. This means our software stays innovative and cutting-edge. These lessons have made us who we are today. By learning and growing, we can make even better software for our clients. Reach out to us today to learn more about how we can help you with your medical device software while making sure we stick to all the rules. Read more about us: https://lnkd.in/eqD2dHYK #zentismedical #softwarepartner #medicaldevices #working #teamwork #tips

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🚨 Important Notice for Companies with Medical Devices in the European Market Attention to all companies with products regulated under Directive 98/79/EC: It is crucial to be aware of the latest regulatory updates affecting the validity of certificates issued by notified bodies. ▶ Effective from July 9, 2024, ◀ the following changes will come into effect: 1️⃣ Extension of certificate validity: Certificates issued under Directive 98/79/EC before May 25, 2017, which were still valid on May 26, 2022, will remain valid until December 31, 2027, provided they have not been withdrawn. 2️⃣ Additional conditions: Certificates that expired before July 9, 2024, may be considered valid until December 31, 2027, if specific requirements are met, such as signing a conformity agreement with a notified body or receiving an exemption from the competent authority of a Member State. 3️⃣ Market introduction deadlines: Depending on the product class, different deadlines for market introduction are established under the new Regulation. It is essential for all affected companies to review their current certificates and take necessary actions to comply with the new provisions before the indicated deadlines. For further details on how these changes may impact your company and products, we recommend consulting with your legal advisor or contacting a notified body directly. Stay informed and prepared to comply with updated regulations. Don't miss out on these important changes for your business! At CMC, we are ready to advise and assist you with all regulatory changes your company may need. www.cmcmedicaldevices.com #MedicalDevices #EURegulations #Directive98/79EC #Compliance #EuropeanMarket #MDR References

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Drug Delivery devices are key to the future of healthcare @ Home ! We had intense conversations over the last 3 days in Antwerp during the "Medical Devices & Connected health" conference organized by PDA - Parenteral Drug Association and post-event "The future of Drug Delivery" workshop. Drug delivery devices 💉 are an essential component to unlock value along the care journey allowing people to forget about their conditions while improving engagement and outcomes, allowing physicians and hospitals 🛌 to care about the ones that need it the most and allowing payers 💲 to know what they are paying for. All that while reducing overall healthcare carbon footprint 🌏. Behavioral design, connected healthcare, cybersecurity, large-volume injectors for @ Home use and devices sustainability impact were discussed deeply. Thanks to PDA, to the conference co-chairs, to my scientific committee planning colleagues and fellow panelists. Caroline Lynar, Falk Klar, PhD, Geraint Davies, Paul Greenhalgh, Arnaud Guillet, Philippe Müller, Iain Simpson, Andrei Yosef Ph.D. Stephanie Göbel Paul Upham Serkan Oray Wenyu Dong Andrew Chapman John Burke Philippe Lauwers

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Will you be joining us in Antwerp, Belgium next week for the PDA - Parenteral Drug Association Good Digitalization in Pharma Conference 2024? DON'T MISS THIS: Wednesday - Session 4: AI in Manufacturing. This session is from 9:05-10:35 and will be moderated by Scott Deckebach, Senior Director here at Lachman. From the event agenda: "In this session, we will explore examples of how modern digital solutions are improving our manufacturing processes today and the promise they hold for the future. Specifically, the session presentations will explore how robotics are employed to remove humans from sterile operations for cell and gene therapy, how vision systems are leveraged to improve line clearance, and how RFID is being applied to the individual unit tracking for syringes. The panel discussion will further explore the benefits and essential elements of a successful implementation and entertain audience questions regarding these technologies or manufacturing." To set up time to meet our team on site, head to our online form here: https://lnkd.in/ea9eKkFN For more event info, see here: https://lnkd.in/gDFbW-Xw #AI #ArtificialIntelligence #Compliance #DataIntegrity #Digitalization #CGMP #Pharma #MedicalDevices #Biologics #Quality #PDA

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- Insights on Correct Data Collection and Validation. For full episode check: https://lnkd.in/ebtvrARx Monir El Azzouzi Amandine Broussier #easymedicaldevice #medicaldevice #regulatorycompliance

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-Importance of Design and Alert Systems in Risk Management For full episode check: https://lnkd.in/ebtvrARx Monir El Azzouzi Amandine Broussier #easymedicaldevice #medicaldevice #regulatorycompliance

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4 years 📅 after the designation of the first Notified Body in France under the Medical Device Regulation (GMED), AFNOR Certification has just obtained the status of Notified Body in the scope of the European Regulation 2017/745. 👉 France now has 2 NBs for Medical Devices. This is important news for Medical Device Manufacturers facing growing backlogs and delays when applying for regulatory approval in Europe. It was expected that AFNOR Certification would become a Notified Body in the first half of 2022. #innovation #MedTech https://lnkd.in/eEg4UVGk

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We are thrilled to announce that PHoenix Impact Solutions (PHiS) has entered into an exclusive partnership with Eurobioconcept for the distribution of isolators in the hospital and labo environment in Belgium. This collaboration marks a significant milestone in our mission to enhance healthcare standards and safety. By joining forces with PHoenix Impact Solutions (PHiS) , Eurobioconcept aim to bring state-of-the-art isolators to healthcare facilities across Belgium, ensuring the highest levels of contamination control and patient protection. We are confident that this partnership will drive innovation and improve patient outcomes. The last examples are Ziekenhuis Oost-Limburg (ZOL) and Ziekenhuis Geel who have chosen for the high quality products of Eurobioconcept , who will be the next one 👊? Stay tuned for more updates as we work together to transform hospital environments and set new benchmarks in healthcare excellence !! More info 👉 isolator@phis.be #EuroBioconcept #PhoenixImpactSolutions #HealthcareInnovation #HospitalSafety #Partnership #Belgium #pharmacy ---

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Dynamic changes are happening within our Healthcare Reprocessing department at our facility in Leuven, Belgium. Want to learn more about the effectiveness enhancements our team has been implementing over the last several months and how you can benefit from these actions? Read our new blogpost here: https://ow.ly/JOE650RuEZ2 #Healthcare #Reprocessing #Validations #PatientSafety #LabTesting

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🦠🚫 𝐈𝐧𝐭𝐫𝐨𝐝𝐮𝐜𝐢𝐧𝐠 𝐌𝐞𝐝𝐢𝐏𝐥𝐚𝐬: 𝐓𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐒𝐭𝐞𝐫𝐢𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 Meet the future of sterilization: MediPlas is a genuine alternative for the current low-temp #sterilization processes. Offering an in-situ hydrogen peroxide generation that can be fitted in medical solutions. MediPlas ticks all the boxes for a sustainable, environmentally friendly, and safer sterilization option for the #medicalindustry. 🔬 𝐒𝐞𝐚𝐦𝐥𝐞𝐬𝐬 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐰𝐢𝐭𝐡 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲 Building on the innovative foundation laid out by MediPlas, the technology takes a step further by integrating seamlessly with existing medical environments. This adaptability ensures that #healthcare facilities can enhance their sterilization processes without the need for extensive modifications. By harnessing dielectric barrier discharge (DBD) technology, MediPlas not only provides a potent sterilization method but does so with remarkable efficiency and minimal environmental impact. ♻️ 𝐒𝐮𝐬𝐭𝐚𝐢𝐧𝐚𝐛𝐥𝐞 𝐚𝐧𝐝 𝐒𝐚𝐟𝐞 𝐒𝐭𝐞𝐫𝐢𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐒𝐞𝐧𝐬𝐢𝐭𝐢𝐯𝐞 𝐄𝐪𝐮𝐢𝐩𝐦𝐞𝐧𝐭 Unlike traditional methods that often involve hazardous chemicals or require high energy inputs, our MediPlas operates effectively at lower temperatures, reducing energy consumption and eliminating the use of harmful substances like Ethylene Oxide (EtO). This makes it an ideal candidate for sterilizing sensitive medical equipment—from intricate electronic devices to delicate surgical tools—ensuring they are free of #microbes without compromising their integrity or functionality. Ready to revolutionize your sterilization processes with MediPlas? 👉 https://lnkd.in/erkBj-pk #HealthTech #MedicalInnovation #HealthcareSolutions #TechnologyInHealthcare #MediPlas #Disinfection #Hydrogenperoxide #Nitrogenoxides

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Curious about what makes a coating hemocompatibility? 🩸 Find out the factors that play a crucial role in this video:👇 To find out more, visit our website: https://shorturl.at/gtGI2 #smartreactors #biotech #innovation #healthcare #biomedicaltechnology

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Find out why ISO 15189 is such an important step towards IVDR compliance #IVDR #ISO15189 #BD

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💡 A great achievement for startup LAYCO who are moving on to the final of the Philips Innovation Award. Dieuwertje Drexhage and Thom Weustink started Layco Medical Devices to make the future of #healthcare reusable and sustainable worldwide. 🔬 Motivated by a commitment to equality, they made a conscious decision: "We will not design for waste; but we will innovate for #sustainability and #accessibility." Their innovation, Vela®, addresses these challenges and aims to reduce stillbirths with a cost-effective, manual, and reusable vacuum pump tailored for low-resource healthcare centers. Current vacuum pumps are often expensive, single-use, or require multiple operators, limiting their suitability for such facilities. Among 7 other finalists, LAYCO will pitch their #startup in the Grand Final for a chance to win. 🏆 The Philips Innovation Award is the largest student entrepreneur award in the Netherlands, meant for students and young professionals who want to further develop their startups or ideas. The grand final will take place on the 11th of June in #Rotterdam. Buy your tickets here: https://lnkd.in/eC77v4WN Delft University of Technology | TU Delft | Mechanical Engineering | LUMC Global | Jenny Dankelman | Jan Carel Diehl |

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MedTech Summit 2024 is just around the corner! Antonina Burlachenko, our Head of Quality and Regulatory Consulting, will be joining the conference on June 13-14 in Brussels. Antonina will be happy to discuss AI regulatory compliance, ISO 42001 certifications, medtech regulatory frameworks, quality management systems and innovative AI management solutions. Let’s meet at the event and chat about MedTech and AI. See you there! #MedTech #AICompliance #ISO42001 #MedTechRegulation #AIMedTech #QualityManagement #RegulatoryConsulting

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🎓 Register for the free-to-attend introductory module of our course Medical Device Design & Development for New & Legacy Products taking place this August 27. During this module, you will gain an overview of the regulatory requirements and routes to market for new and legacy products. #educolifesciences #medicaldevicetraining #medicaldeviceregulations

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🌟News from the EUCROF General Assembly in Bucharest! 🌟 Yesterday afternoon, our President Yoani Matsakis and our Business Solutions Manager Christophe Golenvaux had the honor of speaking at the EUCROF General Assembly. It was an inspiring event filled with insightful discussions and innovative ideas for the future of clinical research. Christophe, who serves as the Chairman of the EUCROF Working Group Communication, shared an engaging presentation on the group's activities and their ongoing efforts to enhance communication and collaboration within the clinical research community. Yoani introduced the groundbreaking xShare project, highlighting its vision for the future of health data sharing in Europe. X-Share aims to enable everyone to share their health data in the European Electronic Health Record Exchange Format (#EEHRxF) with the simple click of a button. This "xShare" or "yellow button" will be featured across health portals and patient apps, empowering people to exercise their data portability rights under #GDPR. We are proud to be part with EUCROF of such transformative initiatives and look forward to contributing further to the advancement of clinical research and health data management. #EUCROF #TelemedicineTechnologies #HealthData #ClinicalResearch #Innovation #GDPR #XShare

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