RegNav is powered by best-in-class data science. We spent tens of thousands of hours classifying, labelling, training and ultimately developing a software solution with features that aim to navigate you through the challenge of identifying requirements so you can bring your medical device to market. The rigor of AI combined with human expertise to ensure your medical device has a clear path to compliance. Learn More Here at https://ow.ly/ETkm50SFYrI #RegNav #DataScience #MedicalDevice #ComplianceSolutions #RegulatoryAffairs #MedicalDeviceDevelopment #ElementRegNav #AI
Element RegNav
Medical Equipment Manufacturing
The future of medical device compliance: intelligent, automated, reliable.
About us
Digital compliance conceived, developed, and backed by industry experts. We are reimagining how medical device companies engage with regulation, helping support and accelerate life-enhancing tools to patients. Leveraging over 200-years of testing experience, combined with patent-pending AI technology, RegNav provides a complete picture of safety and performance requirements, to support our customers in bringing medical devices to market sooner.
- Website
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www.RegNav.com
External link for Element RegNav
- Industry
- Medical Equipment Manufacturing
- Company size
- 10,001+ employees
- Specialties
- software, standards, regulatory compliance, FDA 510(k), medical devices, FDA 21 CFR, artificial intelligence, EU MDR & IVDR, CE marking, in vitro diagnostics, regulatory affairs, and UKCA
Updates
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Our expert James Pink on why we developed RegNav.
We've developed Element RegNav over an 18-month period, combining our regulatory expertise with generative AI technology. 💡 Our new platform aims to streamline medical device compliance planning, reducing timelines from months to weeks. 🚀 Andrew Jordan, Chief Digital and Technology Officer, states: "RegNav optimizes compliance planning and accelerates time-to-market whilst maintaining or enhancing product safety." 🏥⚡ This project kickstarts our broader digital strategy, now led by Natalie Seatter, our new VP of Digital. 🌟 Read more in our latest press release: https://ow.ly/KvBP50SE7t2 #MakingTomorrowSaferThanToday #InOurElement #ArtificialIntelligence
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Are you bringing a medical device to market? Most entrepreneurs wait too long to identify the relevant regulations, costing time and money. Find out what you need to do and when! 👇 Download this whitepaper on Accelerating your Medical Device's Route to Market. https://ow.ly/Ms7a50SA0Fq #MedicalDeviceRegulations #MedicalDeviceStartup #FDARegulations #MedDeviceIndustry #RegulatoryAffairs #ElementRegNav #RegNav
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🆕Try our complimentary Product Code Finder to find your FDA product codes for your medical device. Comment below if you like it👇 https://ow.ly/fZg650SrKfm #MedicalDevice #ProductCode #DeviceRegulation #MedicalDeviceCompliance #elementregnav #regnav
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Element RegNav reposted this
We are thrilled to announce the appointment of Natalie Seatter as our new Vice President of Digital! 🎉 Natalie joins Andrew Jordan‘s tech leadership team with responsibility for Element's global digital strategy. 💻🌍 With a stellar track record in digital transformation and product innovation, Natalie joins us from OAG, the global leader in travel data and insights, where she was Chief Product Officer. She has also led digital transformation at Camelot Lottery Solutions and held senior roles at Worldpay. 🚀 Natalie's focus will be on leading RegNav, our recently launched regulatory intelligence platform that leverages AI to streamline the 'go to market' process for medical device manufacturers. 🌐🏥 Learn more about RegNav here: https://lnkd.in/eEsvdUB9 In addition, Natalie will also explore other digital opportunities as part of our drive towards #MakingTomorrowSaferThanToday. Welcome to the team, Natalie! 🌟 #DigitalInnovation #InOurElement
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Are you a medical device manufacturer and/or innovator struggling to navigate the complex regulatory framework? RegNav is an expert-backed, AI-enabled solution that provides your team with verified safety and performance requirements for your medical device in less than 2 weeks. Let RegNav streamline your process and give you confidence in your submission. See how it works at https://ow.ly/V2zl50SqYxF
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The medical device industry is highly regulated, but with RegNav. we make it easier for manufacturers and innovators to navigate the complex regulatory process. RegNav identifies the safety and performance requirements, creating a comprehensive plan that increases confidence in the submission for medical devices. Have you already identified your applicable standards? Let RegNav verify it for you with a free gap analysis. Find out more about our plan options here. https://ow.ly/JRKz50SpvHA #MedicalDeviceIndustry #RegulatoryCompliance #MedicalDeviceManufacturing #FDACompliance #HealthcareRegulations #MedicalDeviceExperts #CompliancePlan #elelementregnav #regnav
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Looking for insights to bring your medical devices to market efficiently? Download 👇 this whitepaper to avoid pitfalls and missteps along the way, written by Element RegNav medical device compliance experts. Nicole Small Michael Kipping James Pink https://ow.ly/Y9X850SlTZm #MedicalDevices #MedicalTechnology #RegulatoryCompliance #MedicalDeviceDevelopment #Whitepaper #RegNav #ElementRegNav
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📣 It's official! Our first AI-powered product that enables safer and more reliable medical device development is here! 🎉 RegNav combines expert insight with generative AI to support medical device manufacturers in their regulatory journey for FDA submission. Read more in our official press release here. https://ow.ly/TE7t50Sj4wr #MedicalDeviceDevelopment #RegulatoryJourney #FDAsubmission #RegulatoryCompliance #ElementRegNav #RegNav
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Add peace of mind to your regulatory plan for medical devices with solutions from RegNav. We will work with you to identify a proposed FDA product code, its classification, submission type, and applicable standards. We can create a comprehensive list of standards and requirements for your device in less than 2 weeks or, if you have an existing compliance plan, we can verify it for free. Learn more here. https://ow.ly/6sSt50S9KsJ #RegulatorySubmission #RegulatoryPlan #MedicalDevices #FDACompliance #RegNav #ElementRegNav #safety
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