𝗧𝗵𝗲 𝗣𝗼𝘄𝗲𝗿 𝗼𝗳 𝗮 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝘁𝗼𝗰𝗼𝗹! In a quick Q&A, Sara Contu and Lindsay Wright highlight why having a protocol is essential in literature reviews. 👉 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: 🌿 Structured Planning: A protocol ensures your literature review is consistent and reproducible from the start. 🌿 Objective Methods: It documents systematic, unbiased methods, crucial for transparency and regulatory compliance. 🌿Avoid Nonconformities: Helps prevent missing steps and reduces the risk of nonconformity comments. Need assistance with your literature review protocol? 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
Fern.ai
Desktop Computing Software Products
Monroeville, Pennsylvania 911 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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𝗣𝗿𝗲𝘀𝗲𝗻𝘁 𝘆𝗼𝘂𝗿 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄 𝗥𝗲𝘀𝘂𝗹𝘁𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗥𝗶𝗴𝗵𝘁 𝗪𝗮𝘆! In a quick Q&A, Sara Contu and Bethany Knorr Chung, PhD, RAC share best practices for presenting literature review results. 👉 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: 🌿 Detailed Documentation: Start with a full report of your search terms and results, organized by database. 🌿 Citation Table: Include both included and excluded articles, along with reasons for inclusion/exclusion. 🌿 Data Extraction Table: Summarize key findings for safety and performance outcomes—this is the heart of your review. This approach ensures transparency and reproducibility, and meets regulatory expectations. Need guidance on your literature review presentation? 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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🌿 Don’t Overlook Non-English Articles! In a recent Q&A, Sara Contu and Torrie DeGennaro tackle a crucial question: 𝑊ℎ𝑦 𝑠ℎ𝑜𝑢𝑙𝑑𝑛'𝑡 𝑛𝑜𝑛-𝐸𝑛𝑔𝑙𝑖𝑠ℎ 𝑎𝑟𝑡𝑖𝑐𝑙𝑒𝑠 𝑏𝑒 𝑒𝑥𝑐𝑙𝑢𝑑𝑒𝑑 𝑤𝑖𝑡ℎ𝑜𝑢𝑡 𝑗𝑢𝑠𝑡𝑖𝑓𝑖𝑐𝑎𝑡𝑖𝑜𝑛? 👉 𝗞𝗲𝘆 𝗣𝗼𝗶𝗻𝘁𝘀: 🌿 Avoid Bias: Excluding these articles can introduce significant bias into your literature review. 🌿 Comprehensive Insight: Non-English sources often contain critical data, especially important in diverse regulatory environments like Europe. Including these articles ensures a thorough, balanced, and unbiased review. 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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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
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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