For most MedTech professionals, it feels like a never-ending uphill battle when it comes to regulatory documentation. Versions get lost. Updates get missed. Deadlines loom. But what if Fern.ai could change the game? 😎 On November 20th, Sara Contu will be at the #Horizon Conference in Copenhagen, taking the stage to share insights on: 𝗔𝗜-𝗣𝗼𝘄𝗲𝗿𝗲𝗱 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗮𝗻𝗱 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 ✨ She’ll dive into: • How AI simplifies complex workflows. • Strategies to cut redundancy while boosting accuracy. • The role of human-in-the-loop AI for smarter compliance. 👉 Will we see you there? Drop a 🌿 if you’re attending! #MedTech #TechEnabled #RegulatoryConsulting #RegulatoryCompliance #DigitalTransformation #AI #Healthcare #SmartAuthoring #LiteratureReview #ComplianceSolutions #MedicalDevices #FDA #MDR #IVDR #DigitalSolutions #Fern
Fern.ai
Desktop Computing Software Products
Monroeville, Pennsylvania 889 followers
Confidence. Clarity. Compliance.
About us
Fern.ai™ is a life sciences-focused AI / ML platform delivered by the Technology Solutions group, an independent business at RQM+. Our solutions are tailored to empower clients in seamlessly managing compliance requirements and efficiently navigating the dynamic regulatory landscape. By leveraging Fern.ai, you can effectively introduce new products to the market and ensure their continued success while efficiently maintaining regulatory compliance. Fern.ai is the only comprehensive platform for clinical evidence review and delivers quality, speed to market, and supports compliance from concept to commercialization. By leveraging RQM+’s 40 years of regulatory expertise and the comprehensive clinical trial, lab, reimbursement, and consulting services, Fern.ai can assist in reducing regulatory risk and support our clients throughout their product lifecycle. Fern.ai was originally developed in 2020 by Giotto.ai and marketed as Giotto Compliance. RQM+ recently acquired Giotto Compliance and today Giotto.ai and RQM+ partner to bring over 250 years of tech experience to bear. Together, we are expanding Fern.ai into the end-to-end platform for regulatory compliance. To see Fern.ai in action, contact us at: https://fern.ai/book-a-demo
- Website
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https://fern.ai/
External link for Fern.ai
- Industry
- Desktop Computing Software Products
- Company size
- 501-1,000 employees
- Headquarters
- Monroeville, Pennsylvania
- Type
- Privately Held
- Founded
- 2023
- Specialties
- Systematic Literature Reviews, Clinical Evidence, EU MDR, EU IVDR, Post-Market Surveillance, MedTech, and Clinical Evaluations
Locations
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Primary
2790 Mosside Blvd
800
Monroeville, Pennsylvania 15146, US
Employees at Fern.ai
Updates
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Fern.ai reposted this
🎙️ Senior Vice President of Scientific Affairs, Amie Smirthwaite, PhD, FRAPS, recently caught up with Aldo Podestà of Giotto.ai to discuss clinical evaluations, AI in #MedTech, Fern.ai Smart Authoring, and more. 👇 #RegulatoryAffairs #AI #EUMDR #HealthTech
The EU MDR has significantly increased the burden on manufacturers to provide clinical and post-market surveillance data. In my recent conversation with Amie Smirthwaite, PhD, FRAPS, Senior Vice President at RQM+, we discussed how meeting these requirements is crucial for patient benefit and faster market access. With Fern.ai and the Smart Authoring workflow, notified bodies can accelerate the review process, providing precise and up-to-date insights that streamline compliance. Thanks to Amie for the insightful exchange! 🎥 Stay tuned – our second podcast episode featuring all conversations with RQM+ experts is coming soon! ⏰🎥
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𝗪𝗵𝘆 𝗦𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗘𝗻𝗱𝗽𝗼𝗶𝗻𝘁𝘀 𝗠𝗮𝘁𝘁𝗲𝗿? In a quick Q&A, Sara Contu and Lindsay Wright discuss the importance of defining safety and performance endpoints in literature reviews. 👉 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: 🌿 Focused Review: These endpoints guide your literature review towards specific, measurable outcomes related to the device's performance and safety. 🌿 Regulatory Compliance: Defining these endpoints ensures your review provides strong evidence to support safety and performance claims, meeting regulatory requirements. Need help with your literature review? Let’s connect! Comment below or leave us a message! #MedTech #MedTechInnovation #RegulatoryCompliance #SmartAuthoring #Fern #AI #Confidence #Clarity #Compliance #EUMDR #EUIVDR #FDA #HealthCanada #UKCA #NMPA #Regulations #DigitalSolution #SmartAuthoring #SmartKeys #LiteratureReview
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𝗪𝗵𝘆 𝗮 𝗣𝗥𝗜𝗦𝗠𝗔 𝗖𝗵𝗮𝗿𝘁 𝗶𝘀 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗳𝗼𝗿 𝗬𝗼𝘂𝗿 𝗥𝗲𝘃𝗶𝗲𝘄? In our latest Q&A, Sara Contu and Bethany Knorr Chung, PhD, RAC discuss the power of the PRISMA chart in literature reviews. 👉 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: 🌿 Visual Clarity: A PRISMA chart offers a clear visual representation of your decision-making process. 🌿 Transparency: It shows inclusion/exclusion criteria across screening levels, ensuring transparency and systematic review. 🌿 Regulatory Compliance: This clarity helps meet regulatory standards and avoids protocol non-conformity issues. Ready to enhance your literature reviews? Let’s connect! Comment below or leave us a message! #MedTech #MedTechInnovation #RegulatoryCompliance #SmartAuthoring #Fern #AI #Confidence #Clarity #Compliance #EUMDR #EUIVDR #FDA #HealthCanada #UKCA #NMPA #Regulations #DigitalSolution #SmartAuthoring #SmartKeys #LiteratureReview
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𝗕𝗼𝗼𝘀𝘁 𝗬𝗼𝘂𝗿 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄𝘀' 𝗖𝗿𝗲𝗱𝗶𝗯𝗶𝗹𝗶𝘁𝘆! In a quick Q&A, Sara Contu and Torrie DeGennaro discuss what should be in an author's credentials for systematic literature reviews. 👉 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: 🌿 CV: Highlight qualifications, education, and clinical experience. 🌿 Declaration of Interests: Disclose any potential conflicts. Following these steps not only meets regulations but also boosts credibility. 💼✨ Need help with your literature reviews? Let’s connect! Comment below or leave us a message! #MedTech #MedTechInnovation #RegulatoryCompliance #SmartAuthoring #Fern #AI #Confidence #Clarity #Compliance #EUMDR #EUIVDR #FDA #HealthCanada #UKCA #NMPA #Regulations #DigitalSolution #SmartAuthoring #SmartKeys #LiteratureReview
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Fern.ai reposted this
In a recent conversation with John Potthoff, CEO of RQM+, we discussed how Fern.ai supports MedTech professionals in handling large volumes of clinical data. Our goal is to ensure compliance and improve outcomes, all while keeping patient safety at the forefront. 🎥 Big thanks to John for the great conversation - More insights and content coming soon! 🎥
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Fern.ai reposted this
We have collapsible cups, screen cleaner*, sunglasses, pens, and an 🍎 Watch giveaway at #MedTechCon booth #631... ...𝗯𝘂𝘁 𝘄𝗲 𝗮𝗹𝘀𝗼 𝗵𝗮𝘃𝗲 𝘁𝗵𝗶𝘀 𝗯𝗿𝗼𝗰𝗵𝘂𝗿𝗲. If you have 𝘢𝘯𝘺 questions about how RQM+ works with clients and the #MedTech industry, take a look. 👁️ 𝗪𝗲 𝗱𝗲𝗹𝗶𝘃𝗲𝗿 𝗲𝗻𝗱-𝘁𝗼-𝗲𝗻𝗱 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗮𝗰𝗿𝗼𝘀𝘀 𝘁𝗵𝗲 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗹𝗶𝗳𝗲𝗰𝘆𝗰𝗹𝗲. 𝗪𝗲 𝗮𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗲 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗺𝗮𝗿𝗸𝗲𝘁 𝘀𝘂𝗰𝗰𝗲𝘀𝘀. ➕ RA/QA Consulting ➕ Clinical Trials ➕ Jordi Labs, an RQM+ Company ➕ Reimbursement ➕ Fern.ai *𝘍𝘢𝘷𝘰𝘳𝘪𝘵𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘩𝘶𝘮𝘢𝘯 𝘱𝘰𝘴𝘵𝘪𝘯𝘨 𝘵𝘩𝘪𝘴. #MedicalDevices #IVDs The MedTech Conference AdvaMed
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We're looking forward to Regulatory Affairs Professionals Society (RAPS) Convergence 2024! Have you: 🌿 Booked your flight and hotel? 🌿 Scheduled your agenda? 🌿 Make sure to visit the #RQM+ booth 1017 🌿 Learn more about Challenges in Developing Medical Technologies for Unmet Medical Needs from Allison Komiyama, PhD, RAC in the Plenary Session Wednesday morning from 8:15 - 9:00 🌿 Learn more about Fern.ai from Jonathan Gimbel and Sara Contu Wednesday 12:25 in the Expo Hall Discover Theater (Booth 239)
🌴 RQM+ will be an Innovator Sponsor at Regulatory Affairs Professionals Society (RAPS) Convergence 2024 in Long Beach, California next week! 4️⃣ 𝘄𝗮𝘆𝘀 𝘁𝗼 𝗳𝗶𝗻𝗱 𝘂𝘀 𝘁𝗵𝗲𝗿𝗲: 𝗦𝘂𝗿𝘃𝗶𝘃𝗼𝗿: 𝗧𝗵𝗲 𝗙𝗗𝗔 𝟱𝟭𝟬(𝗸) 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 (𝗣𝗿𝗲-𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽) (16-17 Sept. | 8:30 AM – 4:00 PM PDT) ↘ RQM+ VP of MedTech Innovations, Allison Komiyama, PhD, RAC, is one of the instructors. She joins Mark DuVal, J.D. FRAPS, Lisa Pritchard, Kathy Herzog, Dongbo Wang, and FDA/CDRH Deputy Ombudsman Ken Skodacek 𝗣𝗹𝗲𝗻𝗮𝗿𝘆 𝗦𝗲𝘀𝘀𝗶𝗼𝗻: 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗶𝗻𝗴 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗨𝗻𝗺𝗲𝘁 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗡𝗲𝗲𝗱𝘀 (Wednesday, 18 Sept. | 8:15 AM – 9:00 AM PDT) ↘ Allison Komiyama, PhD, RAC is a panelist, along with Cheryl Coon, Karl-Heinz Huemer, and Justin West, MD. João Duarte will moderate. 𝗟𝗲𝘃𝗲𝗿𝗮𝗴𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗮𝗻𝗱 𝗦𝗺𝗮𝗿𝘁 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲𝘀 𝘁𝗼 𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝗘𝗨 𝗠𝗗𝗥 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 (Wednesday, 18 Sept. | 12:25 PM – 12:50 PM PDT) ↘ RQM+ Vice President of Technical, Jonathan Gimbel, will present, and will be joined by Fern.ai Product Manager Sara Contu, MSc. 𝗘𝘅𝗵𝗶𝗯𝗶𝘁 𝗛𝗮𝗹𝗹, 𝗕𝗼𝗼𝘁𝗵 #𝟭𝟬𝟭𝟳 ↘ If you're attending, please stop by! We can't wait to meet and catch up with attendees in person. You can enter for a chance to win a ⌚, too. #MedTech #RAPSConvergence2024 #RegulatoryAffairs #MedicalDevices
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🌿 𝑺𝙥𝒐𝙩𝒍𝙞𝒈𝙝𝒕 𝒐𝙣 𝘾𝒍𝙞𝒏𝙞𝒄𝙖𝒍 𝑬𝙭𝒄𝙚𝒍𝙡𝒆𝙣𝒄𝙚: 𝑨𝙣 𝙀𝒙𝙘𝒍𝙪𝒔𝙞𝒗𝙚 𝙌&𝘼 𝙬𝒊𝙩𝒉 Amie Smirthwaite, PhD, FRAPS 🌿 We recently had the privilege of hosting an insightful interview where Sara Contu, Product Manager at Giotto.ai, sat down with Amie Smirthwaite, PhD, FRAPS, Senior Vice President of Scientific Affairs at RQM+, to explore the intricate world of clinical compliance for #EUMDR and #EUIVDR. 👉 Watch the Full Interview Here 👉 https://lnkd.in/gZMWyQ_j To learn how Fern.ai can help manage clinical data review, join the upcoming Certificate Program with free access to Fern.ai with amazing training content including more sessions from industry experts including Amie Smirthwaite, PhD, FRAPS, Jaishankar Kutty, Ph.D., Jonathan Gimbel, Alexia Haralambous, Margot Borgel, Ph.D., and Niki Caporali Spaniel, RAC. 👉 Join the Certificate Program Here 👉 https://lnkd.in/ek-_aCqw #RegulatoryCompliance #SmartAuthoring #FernAI #SystematicLiteratureReview #MedTech #MedTechInnovation #LiteratureReview #DigitalSolution
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This week we've been sharing a lot about #SystematicLiteratureReviews, but when you go to hit "search" these obstacles can make systematic literature reviews overwhelming. Between juggling multiple platforms that complicate your workflow, and dealing with fragmented processes that reduce your efficiency, it's no wonder most researches have difficulty in maintaining consistent and collaborative SLR results. Sounds familiar? The reality is that these challenges can drain your time and energy, leaving little room for focused research and innovation. 🌿 Discover. A. Better. Way. 🌿 Do you know that you can now consolidate your entire systematic literature review workflow into one seamless platform, enhancing productivity and collaboration? With Fern.ai, We Promise: 🌿 Seamless Integration: Consolidate your literature review process into a single, easy-to-use platform, reducing complexity and increasing efficiency. 🌿 Enhanced Productivity: Streamline your tasks and focus more on research and innovation, rather than administrative burdens. 🌿 Improved Collaboration: Foster better teamwork with tools designed to facilitate clear communication and cohesive project management. Experience the difference for yourself 👉 https://lnkd.in/gefjDPmK #MedTech #RegulatoryCompliance #SmartAuthoring #FernAI #Confidence #Clarity #Compliance #EUMDR #EUIVDR #Regulations #DigitalSolution #SmartAuthoring #SmartKeys #LiteratureReview #RQM+