Fern.ai

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)

🌿 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

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+

🚀 𝙈𝙖𝙨𝙩𝙚𝙧𝙞𝙣𝙜 𝙎𝙮𝙨𝙩𝙚𝙢𝙖𝙩𝙞𝙘 𝙇𝙞𝙩𝙚𝙧𝙖𝙩𝙪𝙧𝙚 𝙍𝙚𝙫𝙞𝙚𝙬 𝙎𝙩𝙧𝙖𝙩𝙚𝙜𝙮 𝙞𝙣 𝙈𝙚𝙙𝙏𝙚𝙘𝙝: 𝘈 𝘒𝘦𝘺 𝘵𝘰 𝘌𝘷𝘪𝘥𝘦𝘯𝘤𝘦-𝘉𝘢𝘴𝘦𝘥 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 🧠🔬 In the rapidly evolving field of #MedTech, conducting a thorough #SystematicLiteratureReview is essential to drive evidence-based innovation and regulatory compliance. 𝙃𝙚𝙧𝙚’𝙨 𝙝𝙤𝙬 𝙩𝙤 𝙢𝙖𝙨𝙩𝙚𝙧 𝙩𝙝𝙞𝙨 𝙘𝙧𝙪𝙘𝙞𝙖𝙡 𝙥𝙧𝙤𝙘𝙚𝙨𝙨: 📋 Start with a Clear PICO Strategy -Define Population (P): Who is the study about? -Identify Intervention (I): What’s being tested or introduced? -Set the Comparison (C): What is it measured against? -Determine Outcomes (O): What results are you looking for? 🔍 Search Smart, Not Hard -Chose the right databases and resources -Use targeted keywords, medical subject headings (MeSH), and Boolean operators to narrow down your search -Aim for quality, relevance, and recency in your sources 📝 Critical Appraisal -Evaluate your results and assess the quality and validity of studies. -Look for biases, sample sizes, and methodology to ensure the evidence is robust and applicable. 🧩 Data Extraction & Synthesis -Systematically extract data and synthesize findings. This is where patterns emerge, and gaps in the literature become evident. Remember, a well-executed systematic literature review not only supports regulatory submissions but also drives innovation by providing a solid foundation of evidence. 🌟 👓 Looking for help with your Systematic Literature Reviews? 👉 https://fern.ai/ #MedTech #SystematicReview #Innovation #EvidenceBased #PICO #MedicalDevices #RegulatoryAffairs #HealthcareInnovation #EUMDR #EUIVDR

🎙 Thank you Alexia Haralambous for shedding light on the evolution of #StructuredContentAuthoring at #FDA. Did you know the FDA has moved toward their own forms of structured content authoring over time? 🌿 𝗔𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵 𝗮 𝗛𝘂𝗺𝗮𝗻 𝗧𝗼𝘂𝗰𝗵: The FDA has started implementing smart templates to promote consistency and efficiency without losing the human element. 🌿 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗥𝗲𝘃𝗶𝗲𝘄: They've adopted techniques like the eSTAR template for #510k submissions and are expanding to pilot Health Canada submissions. 🌿 𝗔𝗹𝗶𝗴𝗻𝗲𝗱 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀: The goal is to ensure submissions align with reviewer memo templates, promoting efficient and consistent review processes on both ends. 🌿 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝗰𝘆 𝗶𝘀 𝗞𝗲𝘆: As the FDA enhances their review processes, it's crucial for companies to ensure their submissions are consistent and efficient. With Fern.ai, you too can benefit from #SmartAuthoring designed to help you achieve this alignment, making your submission process smoother. 👉 https://lnkd.in/gefjDPmK for more insights on maintaining compliance and efficiency through #SmartAuthoring strategies! 📅 Book a demo and experience the difference for yourself. 🤩 #RegulatoryCompliance #SmartAuthoring #Efficiency #MedTech #FernAI #EUMDR #EUIVDR #MedTechInnovation #RQM+

It's frustrating experiencing fragmented workflows and miscommunications across teams when creating or updating regulatory documents. These obstacles disrupt efficiency and your sought-after "flow" when writing. They lead to delays and difficulty maintaining consistent and up-to-date documentation. Sound familiar? These challenges can drain your time and energy, leaving little room for innovation and strategic planning. Discover. A. Better. Way. Do you know that you can now unify your product development workflow and improve collaboration across teams? With Fern.ai, you will have access to: 🌿 Unified workflows that integrate documents seamlessly at every stage, ensuring all teams are aligned and working efficiently. 🌿 Enhanced collaboration tools that strengthen teamwork and facilitate clear communication and cohesive project management. So take a deep breath, lean back in your 4-wheeled chair, have a sip of coffee, and smile. Fern.ai is here to get rid of these frustrations and make life for you and your whole team so much easier!

🌿 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. Dr. Smirthwaite, with her extensive background including leading Global Clinical Compliance at BSI, shared her expertise on the evolving clinical review processes and the critical importance of aligning device performance with clinical benefits under MDR. She highlighted the significance of well-conducted literature reviews and clarified the often-misunderstood distinction between device performance and clinical benefits—a must-know for any manufacturer navigating the stringent MDR standards. 💡 Key Takeaways: ➡ Achieving clear alignment between a device’s intended purpose and its clinical data is crucial for regulatory success. ➡ Systematic literature reviews need a balanced approach to avoid risks associated with overly narrow or broad search criteria. ➡ The integration of clinicians into the review process has transformed how reviews are conducted, ensuring that patient needs remain a top priority. For those in the #MedTech industry, this conversation is a treasure trove of knowledge on navigating the complexities of #EUMDR and #EUIVDR compliance. Don’t miss out on the full interview! 🎥 👉 Watch the Full Interview Here 👉 https://lnkd.in/gZMWyQ_j #RegulatoryCompliance #SmartAuthoring #FernAI #SystematicLiteratureReview

We talk a lot about #SystematicLiteratureReview, but what does this even mean? See for yourself how Fern.ai can benefit you 👉 https://lnkd.in/gefjDPmK #MedTech #RegulatoryCompliance #SmartAuthoring #FernAI #Confidence #Clarity #Compliance #EUMDR #EUIVDR #Regulations #DigitalSolution #SmartAuthoring #SmartKeys #LiteratureReview #RQM+

🎙 Thank you Niki Caporali Spaniel, RAC for explaining the benefits of #StructuredContentAuthoring. 🌿 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲𝘀 𝗮𝗿𝗲 𝗞𝗲𝘆: Many templates are required for technical documentation, each with similar fields for classification, indication, or patient population. 🌿 𝗦𝗺𝗮𝗿𝘁 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝗻𝗴: With structured content authoring, these fields can be populated from a master source, like a product profile, across all documents. 🌿 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗳𝗼𝗿 𝗠𝗲𝗱𝗧𝗲𝗰𝗵: This approach is invaluable in the MedTech industry, where precision, up-to-date information, and consistency are critical. 🌿 𝗘𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 𝗢𝗿𝗴𝗮𝗻𝗶𝘇𝗮𝘁𝗶𝗼𝗻: Structured content authoring helps organize information more effectively, moving beyond simply meeting requirements to telling a consistent and effective story throughout the product lifecycle. 🌿 𝗔𝗹𝘄𝗮𝘆𝘀 𝗨𝗽-𝘁𝗼-𝗗𝗮𝘁𝗲: At Fern.ai, our #SmartAuthoring module ensures your documentation is consistent, precise, and up-to-date, helping you maintain compliance and efficiency. 👉 Find out today how #SmartAuthoring can streamline your technical documentation process! 🌟 https://fern.ai/ #RegulatoryCompliance #SmartAuthoring #Efficiency #MedTech #FernAI #EUMDR #IVDR #RQM+

Calling all #MedTech and #IVD manufacturers- How are you keeping up with ever-changing regulations? 😰 Join us for the #SmartAuthoring Certificate Program—designed for those who want to master regulatory compliance and speed up their product’s path to market. Here’s what you’ll gain: 🌿 A streamlined approach to regulatory compliance 🌿 Advanced document management techniques 🌿 Tips and tricks from industry experts Our previous programs were a hit, helping professionals like you navigate the maze of compliance with ease. And guess what? We're back with even more refined strategies and tools to support your journey. 😎 Don’t miss out on joining our growing community of professionals who are taking their compliance game to the next level. Ready to elevate your expertise? 👉 Apply now for our Certificate Program 👉 https://lnkd.in/ek-_aCqw