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?????? ?????????? ???? ?? ???????????????????? ???????????? ????????????????! In a quick Q&A, Sara Contu and Lindsay Wright highlight why having a protocol is essential in literature reviews. ?? ?????? ????????????: ?? 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

?????????????? ???????? ???????????????????? ???????????? ?????????????? ???? ?????? ?????????? ??????! 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

?? 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

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

??? 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

?????? ???????????? ?????? ?????????????????????? ?????????????????? ????????????? 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

?????? ?? ???????????? ?????????? ???? ?????????????????? ?????? ???????? ????????????? 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

?????????? ???????? ???????????????????? ??????????????' ??????????????????????! 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

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!???

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