Veranex

Need a break from work? How about a word search! Find three words related to integrated product development and comment below with what you found! Bonus points for sharing how you're incorporated them into your strategy! #IntegratedDevelopment #medtech #MedicalDevices #VeranexDevelops

Navigating the complexities of biocompatibility is essential for ensuring safety and compliance in medtech product development. Join our online training on November 21 and 26 to deepen your knowledge and enhance your skills in this crucial area! In this 2-day course, you will: - Develop a foundational understanding of biocompatibility-related issues and requirements - Learn how to avoid costly mistakes when selecting materials - Gain insights to facilitate effective discussions on biological evaluations and much more! Whether you’re new to the field or looking to improve your expertise, this training is for you! Register now: https://hubs.la/Q02X6wXQ0 #Biocompatibility #MedTech #MedicalDevice #Training

In our latest Medtech Pioneers podcast episode, Lisa Carmel talks with Dr. Janani Reisenauer about innovations within surgery at Mayo Clinic. Dr. Reisenauer is the chair of the Division of Thoracic Surgery and Associate Chair of Innovation at the Department of Surgery at Mayo Clinic and the program chair for the Mayo Clinic Beahrs Surgical Innovation Summit. The summit is quickly approaching! We’re honored to be a diamond sponsor and excited to connect with innovators at the forefront of surgical solutions. 🎧 Tune in to the podcast episode now: https://lnkd.in/g4-vYdCW #Surgery #AI #Medtech #SurgicalTraining #Innovation

At this year’s LSI event in Portugal, attendees took a deep dive into the areas of whitespace and disruptive innovation along with the critical factors that can influence success. Here are Lisa Carmel’s key takeaways from moderating a panel on unlocking disruptive innovation and meeting with startups. #LSI #medtech #innovation #MedicalDevices

Preclinical study protocols are foundational to the reports that regulatory bodies require. Therefore, the quality of your study protocols can make or break your study! Learn about the 13 elements you NEED to include in any preclinical study protocols in our latest blog post ➡️ https://hubs.la/Q02WMg6V0 #Preclinical #StudyProtocols #RegulatoryApproval #Medtech

In case you missed it! Hear from Andrew Cleeland, CEO at Fogarty Innovation, and co-moderator of a panel at Mayo Clinic Beahrs Surgical Innovation Summit. We’re excited to share this conversation with you and also for the summit!

⚠️ FDA Update! ⚠️ Did you know that the U.S. Food and Drug Administration recently proposed to reclassify in vitro diagnostic (IVD) HBV tests from Class III (high risk) to Class II (moderate risk) devices? This change will allow IVD manufacturers to pursue the less burdensome 510(k) premarket notification pathway, which has a shorter review timeline than the stringent premarket approval application required for Class III devices. With this reclassification, we anticipate greater interest and investment in the development of qualitative or quantitative point-of-care HBV tests. If you’re... - Developing a singleplex or multiplex point-of-care test - Developing a clinical laboratory analyzer - Or need regulatory support for FDA submission We can provide you with a team of experts to support your project and help you commercialize your IVD test. Get in touch ➡️ https://hubs.la/Q02Wqxc30

Thanks to everyone who attended #BiocompatibilityInsights 2024! Couldn’t make it? Here are some general key takeaways from what was discussed: - There are currently a lot of ongoing discussions regarding the validity of the biological tests recommended by the ISO 10993 series. - Some tests commonly used are used for historical reasons rather than scientific ones. For example, Material Mediated Pyrogenicity (MMP) is considered a myth, as no one seems to be able to prove that it really exists. - The value here of evidence-based toxicology was highlighted. Get more key takeaways related to NAMs, toxicological assessments and chemical characterization below ⬇️ If you are looking for online Biocompatibility training opportunities, our team is hosting a “Basic Biocompatibility” training in November! Learn more and register: https://hubs.la/Q02WqpCP0 #Biocompatibility #BI2024

Navigating #IVD regulations can be challenging to say the least. Gain compliance confidence at our upcoming educational session taking place at the Medicon Village in Lund, Sweden on November 26. You'll learn: - The ins and outs of new stringent regulatory constraints due to IVDR - Study design that will support high-quality clinical performance data - Plus, get a FREE IVDR check up with our team of experts! Register Now: https://hubs.la/Q02WgS350 #IVDR #2024IVDRSprint

Buckle up for this rapid-fire panel session at Mayo Clinic Beahrs Surgical Innovation Summit! Lisa Carmel along with Andrew Cleeland are moderating a panel on the surgical shift to AR and VR, packed full of panelists who are heavy hitters in the space. We’re excited to share what we learn! #MayoClinic #MayoBeahrs #SurgicalInnovation #medtech Pat Donnelly, Ryan Roberts, Lisa Carmel, Kristi Nakayama, Dustin Atkinson, Joseph Ferrara, John Hart, MBA➕, Michael Neidert , Mark Stevenson, Steve Shane, MBA, Nir G., Janani Reisenauer, Chloe Piepho Corey, Bettie Lechtenberg, Andy Danielsen, Randall Cullen, MBA, PMP