Element RegNav

Navigating regulatory requirements for medical devices can be time-consuming, complex, and often a roadblock to market success. That’s why we built RegNav — a powerful tool designed to empower your team with expert-backed safety and performance requirements in less than two weeks. ?? What makes RegNav different? ?Proprietary Knowledge Graph: Connects your device characteristics to FDA regulations, development requirements, and non-clinical tests. ?AI & Machine Learning: Seamlessly navigates complex regulatory landscapes and extracts tailored requirements specific to your devices. ?Expert-backed Validation: Ex-FDA and ex-notified body regulators perform rigorous quality checks to ensure accuracy and compliance. Are you ready to simplify your regulatory process and expedite your market entry? Discover how RegNav can streamline compliance for your team. www.regnav.com/solutions #MedTech #RegulatoryCompliance #AI #MachineLearning #FDA #MedicalDevices #RegNav #Innovation #HealthTech #RegulatoryIntelligence #elementregnav #FDARegulations #ComplianceSolutions

Don't Miss Out! Part 2 of Element RegNav’s medical device safety series is happening Wednesday. This webinar will be particularly useful for attendees who are developing a medical product or have never interacted with a regulatory agency and/or conformity assessment body. Featuring James Pink Michael Kipping David Grimsey Register Here https://lnkd.in/e4twPRH4 #MedicalDevice #Webinar #RegulatoryAffairs #ConformityAssessment #ProductDevelopment #MedicalRegulations #DeviceSafety #Xtalks #RegNav #ElementRegNav

At Element RegNav, we understand that every project is unique. Whether you're conducting due diligence or need a comprehensive regulatory strategy, our expert-backed tool is here to support you every step of the way. ? Already have your standards? RegNav can help verify their completeness and accuracy. ?? Identify your standards from the outset, including product codes and, when applicable, a shortlist of predicates. ??Quickly navigate to product-specific requirements, facilitating detailed planning and informed decision-making. Let’s simplify your regulatory journey together! Learn more at https://ow.ly/N4S650TWh9g #RegulatoryCompliance #Innovation #RegNav #RegulatoryStrategy #ComplianceTools #RegNavSolutions #RegulatoryJourney #ElementRegNav

We are excited for you to join us! James Pink Michael Kipping David Grimsey ??

Don't miss out! ‘Medical Device Safety: The Next Frontier’: features our very own James Pink and Michael Kipping -sharing their involvement with the COVID-19 UK Ventilator Challenge and how these extraordinary efforts to save people’s lives became the seed that grew into RegNav, an AI based platform designed to navigate complex medical device requirements. By attending this webinar, you can expect to learn: -Information required to be able to identify non-clinical safety and performance requirements -How to use standards that are applicable to products -The role of accredited testing facilities and how to access them Register Here ?? https://ow.ly/3TWV50TAw7g #MedicalDeviceSafety #COVID19VentilatorChallenge #RegNav #MedTechInnovation #MedicalDeviceCompliance #VentilatorChallengeUK #AIplatform #ElementRegNav #AIDesign

?? Join Element Materials Technology for an upcoming webinar on the role of an AI-based platform in improving #MedicalDeviceSafety by streamlining development and regulatory processes. ?? Expert speakers from the UK Ventilator Challenge will share insights on how regulatory expectations were adapted to meet urgent needs and how a collaborative, multidisciplinary effort enabled success. This webinar will explore how the AI-based platform navigates complex safety and performance requirements, leveraging international standards and user-defined characteristics to create comprehensive design and development plans. ?? REGISTER HERE: https://buff.ly/486hLpa ??Featured speakers: James Pink Michael Kipping #MedicalDevice #MedicalDevices #Diagnostics #MedicalDeviceRegulation #MedicalDeviceManufacturing #LaboratoryTechnology #MedicalDeviceSafety #MedicalDeviceDevelopment

RegNav now offers a new and expanded set of solutions! We are pleased to unveil the launch of RegNav Premium Plus, which for the first time, includes PRODUCT-LEVEL REQUIREMENTS! No more reading every clause to determine applicability and going through the arduous task of copying everything to a spreadsheet, instead this breakthrough AI-powered solution saves time in bringing medical devices to market that enhance and save lives. New features include: ?? Detailed list of requirements for your medical device ?? Filters so you understand the evidence type needed for each requirement. ?? In-depth expert review for thorough compliance strategy Visit https://ow.ly/iQy150THGYw to discover more about how our innovative solutions can help your regulatory compliance journey! #RegulatoryCompliance #MedicalDevices #RegNav #PremiumPlus #EnhancedPlanning #ProductLevelRequirements #Innovation #MedicalDeviceRegulation #ComplianceStrategy #ElementRegNav

We’re thrilled to be exhibiting at MedTech’s premier event, The MedTech Conference, powered by AdvaMed! Join us where we’ll be showcasing how RegNav's AI powered platform and expert insight is clearing the path for medical device compliance. Be sure to stop by Booth #518 for live demos, insights, and plenty of networking opportunities! See you in Toronto, October 15-17. Register now! https://ow.ly/Rm3150TEyHy #MedTechCon #MTC24 #RegNav #AIPlatform #MedicalDevice #Compliance #Toronto

‘Medical Device Safety: The Next Frontier’: features our very own James Pink and Michael Kipping -sharing their involvement with the COVID-19 UK Ventilator Challenge and how these extraordinary efforts to save people’s lives became the seed that grew into RegNav, an AI based platform designed to navigate complex medical device requirements. By attending this webinar, you can expect to learn: -Information required to be able to identify non-clinical safety and performance requirements -How to use standards that are applicable to products -The role of accredited testing facilities and how to access them Register Here ?? https://ow.ly/3TWV50TAw7g #MedicalDeviceSafety #COVID19VentilatorChallenge #RegNav #MedTechInnovation #MedicalDeviceCompliance #VentilatorChallengeUK #AIplatform #ElementRegNav #AIDesign

Join moderator Michael Kipping In London on October 7th! Details below ??