regenold GmbH

𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗢𝘂𝗿 𝗡𝗲𝘄 𝗙𝗶𝘃𝗲-𝗣𝗮𝗿𝘁 𝗦𝗲𝗿𝗶𝗲𝘀: "𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗶𝗳𝗲𝘁𝗶𝗺𝗲" We’re excited to launch the first instalment of our deep-dive series on the critical topic of 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗶𝗳𝗲𝘁𝗶𝗺𝗲, prepared by our regulatory expert Huguette Tchamko. In 𝗣𝗮𝗿𝘁 𝟭 - 𝗔𝗻 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻, we’ll delve into the fundamentals of medical device lifetime, exploring what it is, what it isn't, and key factors involved in determining a device’s lifetime, including mechanical, biological, and clinical considerations. This series will provide valuable insights into how medical device manufacturers ensure their products remain safe, reliable, and effective throughout their intended use. 👉 Check out 𝗣𝗮𝗿𝘁 𝟭 of our series now, and stay tuned for the upcoming deep dives! #MedicalDevices, #Compliance, #MedTech, #HealthTech

𝗘𝗨 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗠𝗮𝘇𝗲: 𝗛𝗼𝘄 𝘁𝗼 𝗨𝗻𝗹𝗼𝗰𝗸 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 𝗳𝗼𝗿 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 In the fast-evolving world of healthcare innovation, Drug-Device Combination Products (DDCPs) present incredible opportunities—but they also come with complex regulatory hurdles. With overlapping requirements from both pharmaceutical and medical device frameworks, bringing these products to market can feel like an unsolvable puzzle. At regenold GmbH, we take pride in being experts in navigating this maze. Our deep understanding of global regulations and our hands-on experience in guiding DDCPs to market make us the trusted partner you need. We streamline the entire process, minimizing delays and maximizing your product’s potential. 🔍 𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝗳𝗼𝗿 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲? https://lnkd.in/eQ_3nP9A We’ve just launched our 𝗢𝗻𝗹𝗶𝗻𝗲 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗗𝗿𝘂𝗴-𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀, packed with key insights to help you tackle: • Working with Notified Bodies • Obligations concerning MDR, GMP requirements, and specific national laws • How to perform Post-market surveillance • Products not yet defined by existing frameworks …and much more! Check it out here: https://lnkd.in/eQ_3nP9A Don't let regulatory challenges slow down your innovation. 𝗢𝘂𝗿 𝘁𝗲𝗮𝗺 𝗶𝘀 𝗵𝗲𝗿𝗲 𝘁𝗼 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘆𝗼𝘂, whether you’re looking for general advice or have specific product questions. Contact us or 𝗯𝗼𝗼𝗸 𝗮 𝗳𝗿𝗲𝗲 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗮𝘁𝗶𝗼𝗻 today: https://lnkd.in/eAF8seky #CombinationProducts, #DrugDelivery, #MDR, #MedTech, #MedicalDevices

𝗨𝗻𝗹𝗼𝗰𝗸 𝘁𝗵𝗲 𝗙𝘂𝗹𝗹 𝗣𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗼𝗳 𝗬𝗼𝘂𝗿 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 (𝗗𝗶𝗚𝗔) Are you looking to bring your DiGA to market but unsure where to start? We've got you covered with our Guide to Digital Health Applications (DiGA)—a comprehensive resource for navigating the complex world of digital health. 🔍 𝗪𝗵𝗮𝘁'𝘀 𝗶𝗻𝘀𝗶𝗱𝗲? • Key insights into the DiGA framework and authorization conditions. • Answers to common questions like "What is a DiGA?" and "How does it differ from a medical device?" • Step-by-step guidance on getting your DiGA listed, including timelines and necessary documentation. • Pricing strategies and factors that influence your DiGA's value. • Information on regulatory requirements and clinical evidence needed for successful approval. 💡 𝗪𝗵𝘆 𝘆𝗼𝘂 𝗻𝗲𝗲𝗱 𝘁𝗵𝗶𝘀 𝗴𝘂𝗶𝗱𝗲: Since the introduction of the Digital Healthcare Act (DVG), DiGAs have become an integral part of the healthcare system in Germany. But the path to market is intricate and demands a strategic approach. Our guide offers practical tips and expert insights to help you navigate this journey with confidence. 𝗡𝗲𝗲𝗱 𝗵𝗲𝗹𝗽? We don’t just offer information—we provide end-to-end support services, from regulatory strategy to clinical trials, ensuring your DiGA meets all the necessary requirements. 𝗥𝗲𝗮𝗱𝘆 𝘁𝗼 𝘁𝗮𝗸𝗲 𝘆𝗼𝘂𝗿 𝗗𝗶𝗚𝗔 𝘁𝗼 𝘁𝗵𝗲 𝗻𝗲𝘅𝘁 𝗹𝗲𝘃𝗲𝗹? Visit our landing page and explore how we can support you in making your digital health application a success. 𝗖𝗵𝗲𝗰𝗸 𝗼𝘂𝘁 𝗼𝘂𝗿 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 (𝗗𝗶𝗚𝗔) 𝗵𝗲𝗿𝗲: https://lnkd.in/e2Tjnbrf #DiGA #DigitalHealth #HealthcareInnovation #HealthTech #MedicalDevices #RegulatoryCompliance #HealthApp Let’s bring your vision to life!

𝗘𝘃𝗲𝗻𝘁 𝗨𝗽𝗱𝗮𝘁𝗲: We are thrilled to announce that the 𝟵𝘁𝗵 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗦𝘆𝗺𝗽𝗼𝘀𝗶𝘂𝗺 𝗶𝗻 𝗕𝗲𝗿𝗹𝗶𝗻 𝗼𝗻 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟭𝟬 is now 𝗳𝘂𝗹𝗹𝘆 𝗯𝗼𝗼𝗸𝗲𝗱! 🙌 We want to extend a huge thank you to everyone who registered—your enthusiasm for shaping the future of healthcare is truly inspiring. As we countdown to this incredible event, we're particularly looking forward to our DTx Sidetrack: “𝗗𝗧𝘅: 𝗔 𝗝𝗼𝘂𝗿𝗻𝗲𝘆 𝗙𝗿𝗼𝗺 𝗩𝗶𝘀𝗶𝗼𝗻 𝘁𝗼 𝗦𝘂𝗰𝗰𝗲𝘀𝘀”. With an outstanding lineup of speakers and thought leaders, we're set to explore groundbreaking advancements in Digital Therapeutics and AI that are revolutionizing the healthcare landscape. We can't wait to engage with all the brilliant minds attending, dive deep into these critical conversations, and of course, network and unwind in true Berlin style. See you in Berlin soon! #DigitalHealth, #DTx, #AI, #HealthcareInnovation, #PharmaAI, #DigitalTransformation

𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗨𝗽𝗱𝗮𝘁𝗲: 𝗡𝗲𝘄 𝗘𝗥𝗔 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗳𝗿𝗼𝗺 𝟭 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝟮𝟰 As of 1 September 2024, the revised Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use is officially in force. This update marks a significant step forward in aligning ERA requirements with the latest scientific knowledge and streamlining the approach to evaluating the environmental impact of human medicines. 𝗞𝗲𝘆 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲: • 𝗗𝘂𝗮𝗹 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁𝘀: In addition to the risk assessment, every medicinal product must now undergo a specific hazard assessment for Persistent, Bioaccumulative, and Toxic (PBT) properties. • 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗗𝗲𝗰𝗶𝘀𝗶𝗼𝗻-𝗠𝗮𝗸𝗶𝗻𝗴: A new decision tree has been added to guide the Phase I risk assessment process. • 𝗘𝘅𝗽𝗮𝗻𝗱𝗲𝗱 𝗧𝗲𝘀𝘁𝗶𝗻𝗴: Phase II risk assessment requirements have been broadened, with mandatory tests now more comprehensive than before. • 𝗗𝗮𝘁𝗮 𝗦𝗲𝗮𝗿𝗰𝗵: Applicants must now provide a complete literature review for active substances already on the market. 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝗠𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘀𝗮𝘁𝗶𝗼𝗻: Applications submitted on or after 1 September 2024 must adhere to the revised guideline. With our extensive experience in environmental risk assessments and a proven track record in supporting drug development and marketing authorisation, we’re here to help you navigate these new requirements smoothly. 𝗡𝗲𝗲𝗱 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝗰𝗲? Contact us today to ensure your compliance and successful market access: https://lnkd.in/ef9Cdf8R #Healthcare, #Compliance, #RegulatoryAffairs, #MarketAccess, #GlobalHealth

𝗔𝗿𝗲 𝘆𝗼𝘂 𝗳𝗮𝗰𝗶𝗻𝗴 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝘆𝗼𝘂𝗿 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝘆? 𝗜𝘀 𝘆𝗼𝘂𝗿 𝗠𝗗𝗥 𝗖𝗘 𝗰𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝘀𝘁𝘂𝗰𝗸 𝗶𝗻 𝗮 𝘀𝗲𝗲𝗺𝗶𝗻𝗴𝗹𝘆 𝗲𝗻𝗱𝗹𝗲𝘀𝘀 𝗹𝗼𝗼𝗽? We understand how frustrating these delays can be, and we're here to support you. Our team offers mediation to resolve challenges swiftly and effectively, whether through improving collaboration with your current Notified Body or guiding you through the transition to a new one. Here’s how we can support you: 𝗥𝗲𝘀𝗼𝗹𝘃𝗲 𝗜𝘀𝘀𝘂𝗲𝘀 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁𝗹𝘆: • 𝗧𝗿𝗼𝘂𝗯𝗹𝗲𝘀𝗵𝗼𝗼𝘁𝗶𝗻𝗴 𝗮𝗻𝗱 𝗠𝗲𝗱𝗶𝗮𝘁𝗶𝗼𝗻: We step in to mediate and troubleshoot issues with your Notified Body, ensuring clear and effective communication to get your certification process back on track. • 𝗙𝗮𝗰𝗶𝗹𝗶𝘁𝗮𝘁𝗶𝗻𝗴 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻: By acting as a bridge between you and your Notified Body, we streamline the process, reducing misunderstandings and delays. 𝗦𝘄𝗶𝘁𝗰𝗵𝗶𝗻𝗴 𝗡𝗼𝘁𝗶𝗳𝗶𝗲𝗱 𝗕𝗼𝗱𝗶𝗲𝘀: • 𝗦𝗺𝗼𝗼𝘁𝗵 𝗧𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻𝘀: Contrary to popular belief, you can change your Notified Body during the transition period and even during ongoing conformity assessment procedures. • We have already supported our clients in navigating this process and successfully initiated a new conformity assessment within just 1 to 3 months. Don’t jeopardize your CE-mark. Take action now to secure a smooth and timely MDR CE certification process. For more information on how we can make this transition seamless for you, please contact us today. #MedicalDevices, #MedTech, #MDR, #EUMDR, #NotifiedBody

𝗔𝘂𝗳 𝗱𝗲𝗿 𝗦𝘂𝗰𝗵𝗲 𝗻𝗮𝗰𝗵 𝗲𝗶𝗻𝗲𝗺 𝗝𝗼𝗯? 𝗖𝗵𝗲𝗰𝗸! Wir verstärken das regenold Team und suchen Dich als 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 𝗜𝗩𝗗 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 (m/w/d): Weitere Details zur Stelle findest du unter: https://lnkd.in/edCh7T6J Mehr Karriere Möglichkeiten findest Du hier: https://lnkd.in/eWJ6FYjJ

𝗿𝗲𝗴𝗲𝗻𝗼𝗹𝗱 𝗚𝗺𝗯𝗛 𝗲𝘅𝗽𝗮𝗻𝗱𝘀 𝗶𝘁𝘀 𝗶𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗻𝗲𝘁𝘄𝗼𝗿𝗸 𝗮𝗻𝗱 𝘀𝗲𝗿𝘃𝗶𝗰𝗲 𝗼𝗳𝗳𝗲𝗿𝗶𝗻𝗴𝘀 𝘁𝗼 𝗦𝘄𝗶𝘁𝘇𝗲𝗿𝗹𝗮𝗻𝗱 𝗯𝘆 𝗮𝗰𝗾𝘂𝗶𝗿𝗶𝗻𝗴 𝗠𝗲𝗱𝗶𝘂𝘀 𝗔𝗚! Medius AG, established in 1997 by Urs Rickenbacher and based near Basel, Switzerland, is a renowned service and consulting firm for pharmaceutical and healthcare products. As a marketing authorization holder, Medius assists companies in approving and marketing their products in Switzerland. regenold GmbH has been successfully operating in Switzerland for several years, with a consistent demand for our services from Swiss customers and companies aiming to enter the Swiss market. This partnership enables us to meet this demand with local qualified resources and extended domain expertise. Medius AG, with its broad expertise, strong customer base, and Swissmedic-approved establishment license, ideally complements regenold’s offerings. We look forward to the opportunities this partnership brings and to continuing our commitment to excellence in the healthcare products industry. #RegulatoryServices #Pharmaceuticals #GDP #MarketAccess #LifeCycleManagement 𝗛𝗼𝘄 𝗰𝗮𝗻 𝗠𝗲𝗱𝗶𝘂𝘀 𝗔𝗚 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘆𝗼𝘂𝗿 𝗯𝘂𝘀𝗶𝗻𝗲𝘀𝘀? 1. Marketing Authorisation Applications for Switzerland can only be submitted to Swissmedic by local companies holding an establishment licence. By using Medius as local MAH, foreign pharmaceutical companies can profit from a fast and cost-efficient product approval and market entry. 2. Acquisitions or divestments in the pharmaceutical industry often require marketing authorization transfers and the need for temporary arrangements until restructuring is completed. Medius can act as a temporary MAH, providing an intermediate solution for securing ongoing market supply of your product. For more information please contact Manuel Vögtli or visit www.medius.ch

𝗝𝗼𝗶𝗻 𝗨𝘀 𝗮𝘁 𝘁𝗵𝗲 𝟵𝘁𝗵 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝗦𝘆𝗺𝗽𝗼𝘀𝗶𝘂𝗺 𝗶𝗻 𝗕𝗲𝗿𝗹𝗶𝗻 𝗼𝗻 𝗦𝗲𝗽𝘁𝗲𝗺𝗯𝗲𝗿 𝟭𝟬! Are you ready to explore the future of digital health? Then don't miss Arvato´s Healthcare Symposium which for the first time will include a DTx Sidetrack: “𝗗𝗧𝘅: 𝗔 𝗝𝗼𝘂𝗿𝗻𝗲𝘆 𝗙𝗿𝗼𝗺 𝗩𝗶𝘀𝗶𝗼𝗻 𝘁𝗼 𝗦𝘂𝗰𝗰𝗲𝘀𝘀” presented by Arvato Systems and regenold GmbH and expertly moderated by Luisa Wasilewski and Oliver Hilgers. 𝗪𝗵𝗮𝘁’𝘀 𝗶𝗻 𝗦𝘁𝗼𝗿𝗲? Discover how Digital Therapeutics (DTx) and AI are revolutionizing healthcare. Gain hands-on insights and learn from real-world success stories shared by industry leaders. Our esteemed speakers include: Koen Kas: “How the Latest in DTx and AI is Shaping the Future of Healthcare” brainjo GmbH: “Taking Digital Therapies to a New Dimension - VR Therapy for Paediatric Patients” (live demo) Dr. Kai-Uwe Morgenstern: “The Use of LLM in Digital Therapeutics” (live demo) Prof. Dr. Pia Wülfing: “Insights into a Successful DiGA Journey” 𝗕𝗲 𝗣𝗮𝗿𝘁 𝗼𝗳 𝘁𝗵𝗲 𝗖𝗼𝗻𝘃𝗲𝗿𝘀𝗮𝘁𝗶𝗼𝗻 Engage in a dynamic Panel Discussion, where your questions and input will drive the dialogue forward. 𝗨𝗻𝘄𝗶𝗻𝗱 𝗮𝗻𝗱 𝗡𝗲𝘁𝘄𝗼𝗿𝗸 𝗶𝗻 𝗦𝘁𝘆𝗹𝗲 After a day of enriching sessions, join us for a guided boat tour along Berlin’s scenic waterways, a visit to the iconic Berlin Cathedral, followed by a luxurious evening dinner and an exciting Casino night! 𝗣𝗹𝗮𝗰𝗲𝘀 𝗮𝗿𝗲 𝗳𝗿𝗲𝗲 𝗯𝘂𝘁 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 – secure your spot today! Register Now: https://lnkd.in/d8KuVTYw Let’s shape the future of healthcare together. See you in Berlin! #DigitalHealth #DTx #AI #HealthcareInnovation #PharmaAI #DigitalTransformation #DataManagement

𝗘𝗨 𝗔𝗜 𝗔𝗰𝘁 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟮𝟰/𝟭𝟲𝟴𝟵: 𝗞𝗲𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗮𝗻𝗱 𝗜𝗺𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 The EU AI Act Regulation (EU) 2024/1689 has been officially published in the EU official journal as of July 12, 2024. This landmark legislation is set to reshape the landscape of artificial intelligence within the European Union, emphasizing safety, transparency, and accountability. 𝗞𝗲𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀: • 𝗥𝗶𝘀𝗸-𝗕𝗮𝘀𝗲𝗱 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: AI systems are categorized as low-risk, high-risk, or unacceptable risk. High-risk systems face stringent requirements, while unacceptable risks are banned. • 𝗧𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆 𝗮𝗻𝗱 𝗔𝗰𝗰𝗼𝘂𝗻𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆: Developers must provide clear information about their AI systems, ensuring users understand how decisions are made. • 𝗗𝗮𝘁𝗮 𝗚𝗼𝘃𝗲𝗿𝗻𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗤𝘂𝗮𝗹𝗶𝘁𝘆: High-risk AI systems must be trained on high-quality, unbiased datasets to ensure accuracy and fairness. • 𝗛𝘂𝗺𝗮𝗻 𝗢𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁: Effective human oversight mechanisms are required to allow for human intervention if necessary. • 𝗖𝗼𝗻𝗳𝗼𝗿𝗺𝗶𝘁𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁: High-risk AI systems must undergo rigorous conformity assessments, either internally or through third parties. • 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴: Continuous monitoring of AI systems is required to maintain compliance throughout their lifecycle. 𝗜𝗺𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀: • 𝗙𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗲𝗿𝘀 𝗮𝗻𝗱 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀𝗲𝘀: Increased compliance costs and the need for robust data management, transparency measures, and human oversight mechanisms. • 𝗙𝗼𝗿 𝗨𝘀𝗲𝗿𝘀 𝗮𝗻𝗱 𝗖𝗼𝗻𝘀𝘂𝗺𝗲𝗿𝘀: Enhanced protection, greater transparency, and increased trust in AI technologies. • 𝗙𝗼𝗿 𝗚𝗹𝗼𝗯𝗮𝗹 𝗔𝗜 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻: The EU sets a global precedent, potentially influencing AI regulatory frameworks worldwide. As we embrace this new era of AI regulation, it’s crucial for businesses to prepare and adapt. At regenold GmbH, we specialize in helping manufacturers of medical devices and IVDs navigate these complexities, ensuring a smooth transition to compliance with the new requirements. Stay ahead of the curve and ensure your AI systems are compliant, safe, and trustworthy. For more insights and support, get in touch with us today! #AI #DigitalHealth #MedTech #HealthTech #HealthcareInnovation