Lynn Roberts’ Post

Unlocking the Secrets of Stentgrafts - Dive into the world of groundbreaking medical innovations 👩⚕️🏥 💡🔬Discover how we optimize stent grafts to deliver top-notch performance. Visit our website at www.bioanamedical.com to explore the future of medical devices

Last call for tomorrow’s webinar, "Artificial Intelligence in the Medical Device Industry: Emerging Issues and Best Practices," presented by Covington & Burling LLP. AI-enabled devices are changing the landscape of medical devices and are subject to evolving regulation. Join us to hear from a team of lawyers from Covington as they discuss key considerations for the AI-enabled medical device space, including current best practices for industry participants seeking to take advantage of this powerful new technology. Register for this free webinar before it's too late: https://lnkd.in/gtJ_bvvC

Look around: you may find up to 2 million medical technologies surrounding you.    From everyday objects to innovative solutions, medical technologies are always there for you.    Discover the footprint of the sector by reading the new MedTech Europe’s Facts & Figures Report 2024 🔎 https://bit.ly/3U8Q3AE 

Another Partner Expert Consults in the books. 📝 Thanks to MedTech Innovator partner Greenlight Guru and Etienne Nichols for joining the MTI cohort today and leading an important discussion on the 4 quality system musts in the medical device space. #partnerexpertconsults #mti #medicaldevice #medtech #greenlightguru

Watch this video and see how the access to new innovative medical devices gets more and more complicated for patients in the EU & Switzerland

Interoperability was the word of the day at our recent Medtech webinar. 🤓 67% of participants chose it as the biggest challenge facing the evolution of medical devices. Take a deeper look at this and other core challenges by watching back what was an insightful discussion with William Betten (S3 Connected Health), AJ Shah, MD, MPH (Abbott), and John Rondoni (Inspire Medical Systems). Check out the link, watch it back whenever it suits you, and learn from experts in the field 👉 https://hubs.li/Q02ywnxq0

Start the new year off right! Join CORE-MD Project's webinar next week on 8 January, starting at 17:00 CET. 🕔 Dive into the topic of "Early #clinicalinvestigations of new high-risk medical devices" with EPF's Claudia Louati and fellow speakers. What will be discussed? The learning objectives are: ✔ Understanding the challenges of early clinical investigation in the context of the #medicaldeviceregulation. ✔ Receiving viewpoints and perspectives from #patients, manufacturers, and regulators. ✔ Exploring possible solutions stemming from CORE-MD recommendation. Ready to register? Be part of the conversation! Follow this link for more: https://lnkd.in/eVKctBMn

🩺 How DocCheck is reinventing and mass-producing medical products with Xometry Europe! DocCheck focuses on the reinterpretation and redesign of medical devices and products. The company puts great emphasis on improving the functionality and efficiency of medical devices such as stethoscopes, diagnostic lights, and reflex hammers without compromising on design and aesthetics. DocCheck Thïngs is the company’s own-brand range that specifically concentrates on the product design of its own medical products. 🗞️ Find out more about this exciting story and read the full case study (link in the comments)👇

👏 #Thankyou all for your participation and your great feedback 🙏 . Our #WEBINAR! “All you need is approval” with Custom Medical, Dr. Michaela Kauer-Franz, Dr. Jonas Walter and seleon GmbH, Peter Hartung hit the request of all start-ups. 💪 This event is specially crafted for medical device start-ups who are navigating the complexities of introducing new devices in the European Union (EU) market under the new Medical Devices Regulation (MDR). Breaking into the EU market is a significant challenge, particularly for startups and small companies with limited resources. Our webinar addressed these challenges, providing essential insights and strategies to streamline your journey. Highlights: ✅ Early International Approval Strategies ✅ Streamlining Regulatory and Usability Processes ✅ Learning from Industry Challenges ✅ Gain insights to accelerate market entry and save resources. Special focus on startup needs! #startups #startup #mdr #usability #marketentry #accelerate #founders #regulatoryaffairs #seleon #CustomMedical #Thanks #team #cooperation

ICYMI, CDRH's 2023 Annual Report is out, including reference to the LDT proposed rule, expansion of TAP (the Total Product Life Cycle Advisory Program), reflection on the progress of the Digital Health Center of Excellence, and more. A good way to get caught up on FDA's activity with respect to medical devices in 2023 and prepare for what may be down the road in 2024. #FDA #medicaldevices #healthlaw #lifesciences