?????????????? ???????? ???????????????????? ???????????? ?????????????? ???? ?????? ?????????? ??????! In a quick Q&A, Sara Contu and Bethany Knorr Chung, PhD, RAC share best practices for presenting literature review results. ?? ?????? ????????????: ?? 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
关于我们
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
- 网站
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https://fern.ai/
Fern.ai的外部链接
- 所属行业
- 桌面计算软件产品
- 规模
- 501-1,000 人
- 总部
- Monroeville，Pennsylvania
- 类型
- 私人持股
- 创立
- 2023
- 领域
- Systematic Literature Reviews、Clinical Evidence、EU MDR、EU IVDR、Post-Market Surveillance、MedTech和Clinical Evaluations
地点
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主要
获取路线
2790 Mosside Blvd
800
US，Pennsylvania，Monroeville，15146
Fern.ai员工
动态
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?? Don’t Overlook Non-English Articles! In a recent Q&A, Sara Contu and Torrie DeGennaro tackle a crucial question: ????? ?????????????'?? ??????-????????????? ???????????????? ???? ???????????????? ????????????? ??????????????????????????? ?? ?????? ????????????: ?? 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: ????-?????????????? ???????????????? ?????? ?????????????????? ?????????????????????????? ???????????????????? ? 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转发了
??? 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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?????? ???????????? ?????? ?????????????????????? ?????????????????? ????????????? In a quick Q&A, Sara Contu and Lindsay Wright discuss the importance of defining safety and performance endpoints in literature reviews. ?? ?????? ????????????: ?? 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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?????? ?? ???????????? ?????????? ???? ?????????????????? ?????? ???????? ????????????? In our latest Q&A, Sara Contu and Bethany Knorr Chung, PhD, RAC discuss the power of the PRISMA chart in literature reviews. ?? ?????? ????????????: ?? 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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?????????? ???????? ???????????????????? ??????????????' ??????????????????????! In a quick Q&A, Sara Contu and Torrie DeGennaro discuss what should be in an author's credentials for systematic literature reviews. ?? ?????? ????????????: ?? 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转发了
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转发了
We have collapsible cups, screen cleaner*, sunglasses, pens, and an ?? Watch giveaway at #MedTechCon booth #631... ...?????? ???? ???????? ???????? ???????? ????????????????. If you have ?????? questions about how RQM+ works with clients and the #MedTech industry, take a look. ??? ???? ?????????????? ??????-????-?????? ?????????????????? ???????????? ?????? ???????????????? ??????????????????. ???? ???????????????????? ???????????????????? ?????? ???????????? ??????????????. ? RA/QA Consulting ? Clinical Trials ? Jordi Labs, an RQM+ Company ? Reimbursement ? Fern.ai *???????????????? ???? ?????? ?????????? ?????????????? ????????. #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! ? 4?? ???????? ???? ???????? ???? ??????????: ????????????????: ?????? ?????? ??????(??) ?????????????? ?????????????? (??????-???????????????????? ????????????????) (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 ?????????????? ??????????????: ???????????????????? ???? ???????????????????? ?????????????? ???????????????????????? ?????? ?????????? ?????????????? ?????????? (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. Jo?o Duarte will moderate. ???????????????????? ???????????????????? ?????? ?????????? ?????????????????? ???? ???????????????? ???? ?????? ???????????????? ???????????????????? ?????? ????????-???????????? ???????????????????????? ?????????????????????????? (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. ?????????????? ????????, ?????????? #???????? ↘ 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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