The smarter way to 
get your device to market

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.

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.

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.

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.

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.

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.