The smarter way to 
get your device to market

Fern.ai is the only platform designed to enhance the entire MedTech lifecycle.​

Fern.ai helps your team focus on what matters most: ​
Getting products to market and keeping them there. ​

Creating product documentation and conducting literature reviews can be stressful. ​
Not to mention that it is challenging to keep content aligned with routine updates.​

Alleviate the stress with the only platform that covers the full spectrum of MedTech compliance ​
from strategy and research to documentation and maintenance.​

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Smart Authoring  

Elevate your document development experience with Fern.ai's Smart Authoring module. Smart Authoring combines an editable list of Smart Keys and definitions with all your product content, documents, and definable source material ensuring that wherever such terms and definitions appear many places in a template or in multiple templates, the content is reflected with the most recent version. Using customizable templates allows standardization achieving highest consistency and quality across all documents in your product portfolio.

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Systematic Literature Reviews

Fern.ai introduces a comprehensive platform for conducting systematic literature reviews, designed to streamline your research process with precision and ease. Our all-in-one solution empowers researchers with advanced AI tools, making the literature review process faster, more accurate, and fully tailored to your specific needs.​

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Smart Keys: 
How Fern.ai Stands Apart  

Fern.ai Smart Keys are the building blocks which link your templates, product information, and documents. Start by adding Smart Keys to your templates. Next link product information to the Smart Keys in the Product Profile, then to create your document, select a template with Smart Keys and product information populates automatically. If you update product information, this automatically updates in your documents wherever that content is used.​

About Fern.ai

We’re a team of regulatory compliance experts, software engineers, and MedTech consultants who are committed to leveraging leveraging technology to help our clients bring better medical device and diagnostic products to market, faster. To learn more about our company and platform, visit our About Us page.

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See Fern.ai in action 

Ready to see Fern.ai in action? Book a live demo today and see how Fern.ai can reduce the research and regulatory burdens. 

Fern.ai Use Cases for Smart Authoring

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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? Sop 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.

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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.

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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.

Fern.ai Use Cases for Systematic Literature Review ​

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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.

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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.

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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.

Who We’ve Helped

At Fern.ai, we serve a diverse range of clients, including regulatory bodies and MedTech companies. Our platform is trusted by regulators and industry leaders for its accuracy, efficiency, and ease of use. Our clients include:

enerxen

"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

ward 247

"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

ppl biomechanics

"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

diagnosys

"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

Our Resources

Gain valuable insights into best practices, industry trends, and how Fern.ai can make your workflow 40% more efficient by browsing webinars, blog posts, case studies, and other informative resources.

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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.