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New Product Development
In theory, New Product Development should be a streamlined process with teams working in unison to an aligned objective- getting the product to market. But when you're in the thick of it, why does everyone feel like pulling out their hair? Stop the madness and implement Fern.ai's Smart Authoring module. Smart Authoring allows your team to use your own templates and enables the templates to interact via Smart Keys so content changes can be updated simultaneously wherever the content appears.
Initial Regulatory Submissions
We've all been here before, all teams are ready to work on an initial product submission but unsure of where to start. Stop playing "chicken and egg" and start creating your submission with Fern.ai Smart Authoring. Use seamless interactive templates that will help you make progress on your submission and meet deadlines- no matter your starting point.
Compliance Maintenance
Whether for EU MDR, EU IVDR, FDA, or other regulatory agencies, Fern.ai Smart Authoring will make compliance maintenance a breeze. Simply update any changes throughout the year in the product profile and literature review, and the reports will be automatically updated with the new information streamlining maintenance activities from clinical evaluations and post-market clinical follow-up to post-market surveillance and risk management activities.
Clinical Evaluation for EU MDR and EU IVDR
Our medical device extraction framework can be customized to include clinical and safety outcome measures for any medical device type so that this content is extracted from included articles consistently.
We offer clinical evidence review templates, appraisal guidance, and customizable exports to streamline the creation of clinical evaluation reports ensuring adherence to MDR requirements.
Health Economics & Outcomes Research
Selecting appropriate study designs, outcome measures, and search parameters for Health Economics and Outcomes Research (HEOR) assessments are critical to ensure healthcare decisions are informed from rigorous methodologies.
We provide customizable project frameworks that emphasize the incorporation of real-world data and clinical evidence, leveraging patient-level data, observational studies, and pragmatic trial data to enhance the rigor and validity of your health economic and outcomes research methodology.
Post-Market Surveillance & Vigilance Activities
Use Fern.ai to identify trends in adverse events, device malfunctions, or off-label use to avoid time-consuming searches that if not completed, or not completed correctly, could lead to regulatory non-compliance.
The clinical evidence review process in Fern.ai supports quick and automated literature searches on a cadence you set. This way current literature review data can be included in Periodic Safety Update Reports, Post Market Surveillance Reports, and for ongoing vigilance reporting.
"Fern.ai helped us improve the review process while dramatically reducing the screening time and enhancing collaboration by using a centralized cloud system, overall a value-generating experience."
Mauricio Rodriguez
Managing Partner
"Fern.ai is an excellent all-in-one platform. It was easy implement search strategy words and easy to see which articles were included and excluded. Data extraction to PRISMA diagrams is a brilliant solution, and the time spent on literature reviews was greatly reduced with Fern.ai."
Christian Meyhoff
Founder, Board Member
"We used the Fern.ai Platform to complete our MDR literature review in December 2021. The software was easy to use and resulted in a dramatic reduction in the time required to complete our literature search. The Fern.ai team were very professional, friendly and made themselves available for help and support."
Christine Kieman
Education Officer
"Our company recently discovered Fern.ai to test how it would fare for our niche medical device in preparation for the literature review for our clinical evaluation report. (...) the ability to verify and validate the data in half the time made the decision to purchase. The platform is easy to navigate and the support team is top-notch."
Cathleen Stone
Business Process Coordinator
Fern.ai Miniseries for Systematic Literature Review
The Fern.ai Miniseries provides a step-by-step overview of how to leverage Fern.ai for Systematic Literature Reviews. Embrace research excellence and leverage the latest AI technology to streamline your literature review experience.
How Fern.ai creates efficiencies in clinical evidence review process
Learn more about the benefits the RQM+ team has realized since switching to Fern.ai for clinical evidence review.
The Bright Side of EU MDR
How forward-looking MedTech companies can leverage the legislation to drive innovation in the clinical evaluation, achieve faster approvals, and thereby increase their competitive advantage.
Want to see more?
Fern.ai is the clinical evidence platform that reduces research and regulatory burdens so your documents get approved without debate. What to know more? Watch to see the benefits, workflow, and features of Fern.ai in action.
Have questions?
Ready to make your regulatory processes faster, easier, and more efficient?
Book a demo or register for a free trial to see how the end-to-end Fern.ai solution uses AI to get your submissions done faster and more accurately without taking the human out of the loop.