Veranex

Passionate about design and compliance in medtech? Lead risk management initiatives, ensure quality compliance, and be part of transforming healthcare through cutting-edge solutions. Make an impact! Apply now: https://hubs.la/Q03dr-5M0 #MedTech #Engineering #Hiring

At Veranex, we transform complex clinical requirements into strategic advantages, preventing costly rework while accelerating your path to market. Our expert clinical strategy team evaluates all available options and clearly demonstrates how each one impacts your clinical development journey, empowering you to make informed decisions. Discover how we work with you to identify the most efficient clinical pathway for your medical device and IVD: https://hubs.la/Q03drXT-0 #clinicalstrategy #medicaldevices #IVDs

Developing an AI-enabled medical device? The regulatory landscape is shifting. Recent FDA guidance updates have introduced new requirements for AI/ML-enabled device submissions. We've created a step-by-step guide to help you: ? Understand the latest FDA requirements ? Plan your submission strategy ? Engage effectively with regulators ? Streamline your approval process Read our latest insights on preparing successful marketing submissions for AI-enabled devices. https://hubs.ly/Q03dtC2Y0 #MedicalDevices #HealthcareTechnology #RegulatoryCompliance #ArtificialIntelligence

Congratulations to Inflammatix, achieving FDA clearance for the TriVerity? Test, marking a significant advancement in the field of sepsis diagnosis! Veranex is proud to contribute to this achievement due to the close partnership over the last 5+ years. Providing critical support in product design and engineering, human factors, and usability testing, our teams integrated seamlessly, ensuring that the Myrna? Instrument was developed to meet the highest standards for diagnostic accuracy and usability. Read more: https://hubs.la/Q03dl1f50 #Diagnostics #Sepsis #Innovation #MedicalDevices #Healthcare #FDA

Veranex is pleased to support RAPS Switzerland Chapter's EU MedTech Compliance Summit: Navigating New Timelines, Regulations & Clinical Evidence. This event brings together industry leaders and regulators to provide the latest updates on MDR, IVDR, and clinical evidence requirements. Julianne Bobela-Aebischer, PhD from Veranex will talk about identifying and achieving the right level of clinical evidence on the transition to IVDR. Together with speakers from other medtech organizations, we will share insights and contribute to the discussions on the evolving regulatory landscape. Join us on April 2 in Bern, Switzerland: https://lnkd.in/dpcPAnxN #EUMDR #EUIVDR #MedicalDevices

Struggling with EU MDR documentation? Without expert scientific writing, your medical device's path to market could be blocked. With 200+ Clinical Evaluations performed since 2020 and 170+ peer-reviewed publications, our specialized team helps streamline your path to EU compliance. We tackle everything from systematic literature searches to clinical evaluations and post-market surveillance reports. Don't let documentation delays cost you market access. Swipe to explore our comprehensive scientific writing services for medical device manufacturers and click to book your consultation today: https://hubs.la/Q03d4bLC0 #EUMDR #ScientificWriting #CEMarking

At Veranex, we're simultaneously assessing cardiovascular innovation's past while driving towards its future. This week Lisa Boyle moderated a critical LSI panel exploring "The 3 Trends Driving Cardiovascular Investment, M&A, and Deals in 2025+" – discussions that will shape industry direction . To participate in this evolving conversation and explore opportunities → www.veranex.com/contact

We're looking for a Quality Engineer who is passionate about ensuring medical innovations meet the highest standards. Ready to make a global impact? What drives your passion for quality in healthcare innovation? Apply now: https://hubs.la/Q03cGCYh0

When a large CRO couldn't deliver on a in-progress commitment, our specialized team stepped in to rescue their failing trial. We accelerated enrollment, improved communication, and finished ahead of schedule. This case proves that in clinical trials, focused expertise often delivers better results than sheer size. Is your trial behind schedule? Learn how to save it > https://hubs.la/Q03cGGnn0 #ClinicalTrialRescue #Veranex

We're excited to have our own Jessica Richter working with LSI and MedtechWOMEN to drive innovation and leadership in the industry. Thank you, Jess, for constantly pushing boundaries and setting the example of quality leadership in the medtech space!