Effectum Medical AG - We make innovation happen!

𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝗘𝗳𝗳𝗲𝗰𝘁𝘂𝗺 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗔𝗚: 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗙𝗶𝗹𝗲 𝗥𝗲𝘃𝗶𝗲𝘄𝘀 𝗶𝗻 𝗘𝘂𝗿𝗼𝗽𝗲 Julia Enders and Rolf Kaufmann from Effectum Medical AG recently shared their valuable experiences with technical file reviews in Europe and interactions with notified bodies. Here are the key takeaways: 🔍 Notified bodies are experiencing significant overload, leading to occasional communication challenges. Manufacturers often need to be proactive in seeking responses. 🚀 Good news: Fast-track options are available for manufacturers with similar medical devices already on the market. 👉 Don’t miss Nila-Pia Rähle’s recent article about Effectum Medical Legal Manufacturing Services, which includes the option we provide. https://lnkd.in/dc9c_zYm 📊 Post-MDD era changes: Supplier topics and manufacturing process controls have gained prominence in technical files. Overall documentation requirements have become more demanding. ⏳ Advice: Allocate sufficient time for creating high-quality technical files. The investment in thorough documentation pays off in the long run. As professionals in medical device regulations, we support startups and established enterprises in regulatory questions. #MedicalDevices #RegulatoryAffairs #EuropeanRegulation #EffectumMedicalAG

🚀𝗙𝗶𝗻𝗮𝗹 𝗖𝗮𝗹𝗹!🚀 Don’t miss your chance to join our 𝗤𝗠𝗦 𝗕𝗼𝗼𝘁𝗰𝗮𝗺𝗽 kicking off on 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭𝟰𝘁𝗵! We’ve revamped the program with an even sharper focus on the 𝗗𝗲𝘀𝗶𝗴𝗻 & 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗽𝗿𝗼𝗰𝗲𝘀𝘀, based on feedback from our recent sessions. We’re ready to help guide your QMS journey and set you up for success! 💪✨ 📋 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗺𝗼𝗿𝗲? Check out the updated program below! 💡 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀? Feel free to reach out at: info@effectummedical.com! #QMS #Bootcamp #QualityManagement #DesignAndDevelopment #QMSJourney

Our collaboration with Qualio has significantly improved and streamlined our quality management processes, leading to greater efficiency, enhanced compliance, and improved overall performance. As a dedicated provider for medical device clients, we faced challenges with a manual system and sought a more efficient solution.   By implementing Qualio, we've achieved: ➡ 𝗧𝗶𝗺𝗲 𝘀𝗮𝘃𝗶𝗻𝗴𝘀 for example through automated training management ➡ 𝗦𝘁𝗿𝗲𝗮𝗺𝗹𝗶𝗻𝗲𝗱 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹𝘀 ➡ 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗱 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗰𝗵𝗮𝗻𝗴𝗲 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 and versioning, through Qualio's document management tool ➡ 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝘃𝗶𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 by having our QMS documents in one place, and preventing the existance of several draft versions of the same documents.  ➡ 𝗠𝗼𝗿𝗲 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝘀𝘂𝗽𝗽𝗹𝗶𝗲𝗿 𝗮𝘂𝗱𝗶𝘁 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 and follow-up by means of the supplier tool and the event tools of Qualio This partnership not only improves our internal operations but also empowers our clients to meet compliance standards effectively.   👉 Learn more about our journey here: (Case Study Effectum Medical) https://lnkd.in/du2PYd_N   Contact us to learn more about our partnership with Qualio or for receiving a proposal to beneficial terms. info@effectummedical.com   #EffectumMedical #Qualio #MedTech #eQMS #QualityManagement

Did you know you can meet Rolf Kaufmann and Nila-Pia Rähle during a typical workday in Bern? 🗓️   At the dates listed below, either Nila or Rolf will be working at the Sitem Startup Club (SSC). 🚀 This is your chance to:   ☕ Grab a coffee with them 💬 Ask your burning RA & QM questions 💻 Join them at their desk for a quick exchange   Whether you're a startup enthusiast, entrepreneur, or simply curious, this is the perfect opportunity to connect and learn! 📍 Find the location and all the details about the Sitem StartUp Club (SSC) right here: https://www.ssc.swiss/ #networking #startupcommunity #entrepreneurship #innovation #SitemStartupClub #Bern #meetandgreet #businessinsights

🚀 𝗢𝗽𝗲𝗻 𝗖𝗮𝗹𝗹 📍 Zurich Are you developing cutting-edge #digital #health technology?  Apply for Batch 2 of the Tenity accelerator program! This is your chance to access a vast network of investors, top-tier mentorship, and industry collaboration. Hosted by digital health center bülach and Tenity, the program is designed to help startups thrive and secure their first round of financing. Partnered with Zürcher Kantonalbank, Switzerland’s largest early-stage investor, participants will gain exclusive support from ZKB's startup finance team. Ready to elevate your digital health startup? 🏆 ✨ Learn more: https://lnkd.in/djNhbR2b ✨ Apply now: https://lnkd.in/daCMFXZq ⚡ Deadline: 18th October

🚀𝗙𝗶𝗻𝗮𝗹 𝗖𝗮𝗹𝗹!🚀 Don’t miss your chance to join our 𝗤𝗠𝗦 𝗕𝗼𝗼𝘁𝗰𝗮𝗺𝗽 kicking off on 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭𝟰𝘁𝗵! We’ve revamped the program with an even sharper focus on the 𝗗𝗲𝘀𝗶𝗴𝗻 & 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗽𝗿𝗼𝗰𝗲𝘀𝘀, based on feedback from our recent sessions. We’re ready to help guide your QMS journey and set you up for success! 💪✨ 📋 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁𝗲𝗱 𝗶𝗻 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴 𝗺𝗼𝗿𝗲? Check out the updated program below! 💡 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀? Feel free to reach out at: info@effectummedical.com! #QMS #Bootcamp #QualityManagement #DesignAndDevelopment #QMSJourney

🌟 Exciting times at the MedPhab Symposium in TECHNOPARK® Zürich! 🌟   The event brought together experts from MedTech and Photonics to explore the integration of photonic technologies into medical devices. 🏥🔬   Our very own Severine Cranz delivered an insightful presentation on regulatory strategies in MedTech development. She highlighted crucial considerations for risk analysis, clinical evaluation, and supply chain management throughout the development process. 🚀   A huge thanks to MedPhab for hosting such an impactful event, fostering collaboration and innovation at the intersection of technology and healthcare! #MedTech #Photonics #HealthcareInnovation #TechForGood #RegulatoryStrategies #InnovationInHealthcare #MedicalDevices #Collaboration #RiskAnalysis #ClinicalEvaluation

Great news for Start-ups! 🌟 Our partner offers an amazing chance to scale your business! 📈

𝗝𝗼𝗶𝗻 𝘁𝗵𝗲 𝗺𝗼𝗻𝘁𝗵𝗹𝘆 𝗼𝗻𝗹𝗶𝗻𝗲 𝗤𝗠 & 𝗥𝗔 𝘀𝗲𝘀𝘀𝗶𝗼𝗻 𝗶𝗻 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵 Healthtechpark Zürich-Schlieren, Health Tech Cluster Switzerland and digital health center bülach The next session with Effectum Medical will take place on: 📅 Date & time: 30.09.2024, 4:00 – 5:00 pm 🌐 Online event 🔍 Program: After a short update on current regulatory news, we are ready to answer your specific questions about medical devices, MDSW and in-vitro diagnostics. Profit most by providing your questions in advance! Note that this event is specifically geared at start-ups. ✅ Participation: Free of charge for members of Healthtechpark Zürich-Schlieren, Health Tech Cluster Switzerland and digital health center bülach. Registration: https://lnkd.in/dBnssWa6 🎙️ Speakers: Depending on the previously handed in questions: Rolf Kaufmann, Camilla Messerli and/or Nila-Pia Rähle. ⏱️ Duration: Approx. one hour. #HealthTech #Regulations #IVDR #MDR #OnlineEvent

🌟 We are incredibly proud of Severine Cranz who will be speaking at the Photonic Innovation in MedTech Symposium! Her dedication and expertise truly represent the spirit of Effectum Medical AG as we continue to push the boundaries of MedTech innovation. 🚀 Thank you 🙏 , Severine, for sharing your insights and making innovation possible. Together we are shaping the future of healthcare! #MedTech #Innovation #MedicalDevice #Healthcare