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🌍 MDR Seminar Update: Exploring Global Regulatory Pathways! Over the past two weeks, our seminar series took a deep dive into the theme "Other Countries, Other Customs: Regulatory Requirements for Medical Devices around the world". Led by Christopher Jungnickel, Dr., participants gained a comprehensive understanding of how medical device regulations vary across the globe, focusing on: 🇺🇸 USA 🇨🇳 China 🇧🇷 Brazil 🇯🇵 Japan 🇨🇦 Canada 🇦🇺 Australia Each session highlighted the unique regulatory landscapes, challenges, and pathways in these key markets, providing invaluable insights for navigating international compliance. Thank you to everyone who joined us for these sessions! As the medical device industry becomes increasingly global, understanding diverse regulatory frameworks is essential for success. Stay tuned for more exciting topics ahead! #MDRSeminar #AI #ArtificialIntelligence #MedicalDeviceRegulation #MedTech #Healthcare #Engineering #FAUMT #FAU FAU Erlangen-Nürnberg Medical Valley EMN e. V. Elisa Institute FAPS CRC EmpkinS - Empathokinaesthetic Sensor Technology Joachim Hornegger d.hip-Digital Health Innovation Platform Tobias Zobel Siemens Healthineers BioM Biotech Cluster Development GmbH

[#SCIFI2024] 🏁 Today is the start of 2 intensive days marking the final event of the EIT Health SCI FI 2024 programme hosted by Gdański Uniwersytet Medyczny (Medical University of Gdańsk) in Gdansk, Poland! 🗨️ This morning participants benefitted from recruitment tips and entry opportunities presented by Kathrin Huber from Boehringer Ingelheim and were able to have first-hand advice from the consortium on their CVs.    🛠️ SCI FI participants were assigned real-life cases from our industry partners at the beginning of the programme. Tomorrow, each team will pitch their solutions and be challenged in front of an industry panel: Boehringer Ingelheim and Roche Česká republika. 🎉These two days will be denoted by entertaining visits and it will also be the opportunity to level up industry #networking and #recruitment opportunities for our participants. More info on the SCI FI program ➡️ https://lnkd.in/eDK4wP93 #SCIFI2024 #innovation #healthcare #entrepreneurship #project #training EIT Health Medical University of Lodz Marcin Ciszewski, Ph.D., M.D. Mateusz Dworak 🇵🇱🇪🇺 Maastricht University Rudy Schreiber University of Galway FAU Erlangen-Nürnberg Maryam Mirzaei Medicen Paris Region Hickmah Tagaully Gaëlle MOUTHON Gdański Uniwersytet Medyczny (Medical University of Gdańsk) Joanna Przybytek-Kobierna Boehringer Ingelheim Kathrin Huber Philips FreshBlood HealthTech DEX Innovation Centre (DEX IC) Adam Červenka MADOPA Koster Raphael Barcelona Institute of Science and Technology (BIST) Institute for Bioengineering of Catalonia (IBEC) Cristina Arimany Nardi Centre for Genomic Regulation (CRG) Damjana Kastelic IRB Barcelona Institut Mines-Télécom (IMT)

🌟 MDR Seminar Update: Artificial Intelligence in Healthcare This week, led by Stefan Bolleininger, our seminar focused on one of the most exciting and rapidly evolving areas in medical engineering: Artificial Intelligence (AI). Participants explored the opportunities and challenges of AI within the regulatory framework, diving into topics such as: - Introduction of Software as a Medical Device in the regulatory context - Emerge of the concept "artificial intelligence" in healthcare - Obstacles regulatory perspective - can AI be CE marked? - AI under the EU-MDR - coverage and gaps in the regulatory framework - International perspectives - how is AI in healthcare regulated across the globe - Looking above the rim: SaaS and economic operators - Outlook - where are we heading to in regulations This session provided an in-depth look at the complexities of integrating AI into medical devices, exploring its global impact and the current regulatory landscape. A big thank you to all who participated! Together, we’re navigating the challenges and opportunities that AI brings to the medical field. #MDRSeminar #AI #ArtificialIntelligence #MedicalDeviceRegulation #MedTech #Healthcare #Engineering #FAUMT #FAU FAU Erlangen-Nürnberg Medical Valley EMN e. V. Elisa Institute FAPS CRC EmpkinS - Empathokinaesthetic Sensor Technology Joachim Hornegger d.hip-Digital Health Innovation Platform Tobias Zobel Siemens Healthineers BioM Biotech Cluster Development GmbH

✨ MDR Seminar Update: Exploring 3D Printing in Medical Engineering! On week 2, guided by Stefan Bolleininger, our seminar turned the spotlight on the transformative potential of 3D Printing in Medical Engineering. Attendees had the chance to delve into the latest developments and regulatory considerations, with discussions focused on: - Custom-Made Devices - Adaptable and Patient-Matched Devices - Navigating Regulatory Pathways for 3D-Printed Medical Devices - When to Use Additive Manufacturing The session provided valuable insights into how 3D printing is shaping the future of personalized healthcare while ensuring compliance with regulatory standards. A huge thank you to everyone who joined us to explore this cutting-edge topic! Stay tuned as we continue to uncover key themes in medical device innovation and regulation! #MDRSeminar #3DPrinting #MedicalDeviceRegulation #MedTech #Healthcare #Engineering #FAUMT #FAU FAU Erlangen-Nürnberg Medical Valley EMN e. V. Elisa Institute FAPS CRC EmpkinS - Empathokinaesthetic Sensor Technology Joachim Hornegger d.hip-Digital Health Innovation Platform Tobias Zobel Siemens Healthineers BioM Biotech Cluster Development GmbH

📣MDR Seminar Update: Risk Management in Focus! This Monday, November 4th, our MDR Seminar delved into Risk Management, a critical aspect of medical device regulation. Led by Christian Sauter, this session covered essential topics, including: - Standard ISO 14971:2019 - Risk Acceptance Criteria - The Risk Management Process - Risk Analysis and Control - Risk Management in the Product Life Cycle - Post-Market Surveillance Looking ahead, we’ll continue exploring Risk Management next Monday—building on this foundation to equip everyone with robust tools for navigating MDR compliance. Attendees will engage in practical exercises, working through the full risk management lifecycle to deepen their understanding of these concepts in real-world scenarios. Thank you to everyone participating; we look forward to another insightful session next week! #MDRSeminar #MedicalDevice #Regulation #MedTech #Healthcare #Engineering #FAUMT #FAU FAU Erlangen-Nürnberg Medical Valley EMN e. V. Elisa Institute FAPS CRC EmpkinS - Empathokinaesthetic Sensor Technology Joachim Hornegger d.hip-Digital Health Innovation Platform Tobias Zobel Siemens Healthineers, BioM Biotech Cluster Development GmbH

[#SCIFI2024] 💻 Today was EIT Health SCI FI’s mid-term online event ! 8 teams presented their solutions to the 5 industry cases. It was the opportunity to assess the amazing progress since the programme’s kick-off in August. 🌍 Out of the 98 participants, a total of 35 researchers (9 nationalities) are currently enrolled in the Full Programme ! ✍️ Through 7 modules and 5 bonus courses, the SCI FI programme is giving young researchers the skills needed to transition and thrive as an innovator in the healthcare industry. 🙌 Looking forward to seeing everyone during the final event on 2nd to 4th December in Gdansk, Poland, and all the amazing solutions they found to solve case providers’ challenges ! More info on the SCI FI program ➡️ https://lnkd.in/eDK4wP93 #SCIFI2024 #innovation #healthcare #entrepreneurship #project #training EIT Health Medical University of Lodz Marcin Ciszewski, Ph.D. M.D. Mateusz Dworak 🇵🇱🇪🇺 Maastricht University Rudy Schreiber University of Galway FAU Erlangen-Nürnberg Maryam Mirzaei Medicen Paris Region Hickmah Tagaully Gaëlle Mouthon Gdański Uniwersytet Medyczny (Medical University of Gdańsk) Joanna Przybytek-Kobierna Boehringer Ingelheim Kathrin Huber Philips FreshBlood HealthTech DEX Innovation Centre (DEX IC) Adam Červenka MADOPA Koster Raphael Barcelona Institute of Science and Technology (BIST) Institute for Bioengineering of Catalonia (IBEC) Cristina Arimany Nardi Centre for Genomic Regulation (CRG) Damjana Kastelic IRB Barcelona Institut Mines-Télécom (IMT)

📢 Updates: kickoff to our MDR Seminar Today was the kickoff of the Medical Device Regulation Seminar, organized by the FAU Medical Engineering Profile Center! Today’s in-person session, Introduction to the Medical Device Regulation, led by our experts Maria Henke and Christian Sauter, provided invaluable insights into MDR compliance and its complexities. They covered the following topics: - Regulatory Framework for Medical Devices (focus EU) - Classification - Conformance Assessment Procedure - General Safety and Performance Requirements  - Technical Documentation - (Harmonized) Standards  - Post market surveillance Looking forward, the seminar continues next Monday with the topic Risk Management I Thank you to all who attended today, and we can’t wait to see you next week! #MedicalDevices #MDR #Regulation #Healthcare #Engineering #FAUMT #FAU #MedTech FAU Erlangen-Nürnberg Medical Valley EMN e. V. Elisa Institute FAPS CRC EmpkinS - Empathokinaesthetic Sensor Technology Joachim Hornegger d.hip-Digital Health Innovation Platform Tobias Zobel

🙏 Thank You to Our Mentors! 🙏 A big shoutout to the incredible mentors of the MedTech Bootcamp 2024!  Your guidance, expertise, and support were key to shaping the success of our teams. The Medical Engineering Profile Center appreciates your time and commitment to helping the next generation of MedTech innovators thrive. Catherine Schreiber, Mariusz Mąsior, Stephan Witt, be-on-Quality GmbH, Stefan Bolleininger, Jonas Friedrich #MTBC24 #MedTech #Mentorship #Innovation #ThankYou EIT Health FAU Erlangen-Nürnberg Medical Valley EMN e. V. IESE Business School Instituto Pedro Nunes

🧐Transform your research discoveries into real-world applications! FAU invites you to the event “From Science to Start-up," where you'll learn how to bring your scientific insights to market as a startup. Join us on 18 November 2024 for expert advice, exciting entrepreneurship stories, and networking opportunities! #FromScienceToStartup #FAU #InnovationinBavaria #Startups #ScienceTranslation

🎉 Congratulations on all MTBC 24 teams for completing the fine intensive training program 2024🎉 A huge thank you to all of our talented startups Bioliquid Innovative Genetics, SL., Loutkar Robotics, Lucky Loop Medical, Lampsy Health, NumeriCor GmbH, AutoCast Diabetic foot care, Alto Health, ESTVITAL Technologies, Sensimply and Breathe Assist for their hard work and exceptional pitches. You all brought incredible ideas to the table! We are thrilled to announce that Sensimply has won the Final Pitch of the MedTech Bootcamp 2024! 🏆 Their innovative solution truly impressed our jury with its cutting-edge technology, strong market potential, and clear vision for the future of healthcare. Special thanks to our jury for their insights and thoughtful feedback: Jorge Pimenta, Marco Wendel, Jürgen Schüttler, Andreas Bauer and Christoph Heynen 👏 And last but not least, thanks to all partners FAU Erlangen-Nürnberg, Instituto Pedro Nunes, IESE Business School, Medical Valley EMN e. V. and Universitätsklinikum Erlangen 🤩 All this would not have been possible without each and every one of you! 🙌 We’re excited about the next steps and the impact these startups will make in shaping the future of healthcare. 🚀 #MTBC24 #MedTech #Innovation #FinalPitch #Sensimply #EITHealth #MedTechBootcamp