RQM+ Releases Smart Authoring Module for MedTech

RQM+ has debuted the Fern.ai Smart Authoring module to its platform of regulatory documentation services for medical device organizations.

Together with Systematic Literature Review, the modules are set to enhance compliance, accuracy, and efficiency in medtech regulatory documentation. Fern.ai’s Smart Authoring module is designed to meet complex regulatory challenges by offering an intelligent solution that automates and streamlines the creation, management, readiness, and ongoing regulatory document maintainence.
 
Fern.ai’s key features and benefits include:

• Single Source of Truth: Smart Keys and product profiles provide a single source of truth with version control and common terminology and style
• Template Management and Alignment: Readily update content within the product profile and populate product information across templates automatically
• Dynamic Linking Across Documents: Smart Keys readily adapts to content changes and enables collaboration across authors
• Enhance Team Collaboration: Provide access to cross-functional users for in-platform comments and editing
• Streamline Literature Reviews: Conduct literature reviews in Fern.ai and add outputs directly into product documentation via Smart Authoring integration 

Fern.ai Smart Authoring addresses the critical need of speed and accuracy for regulatory documents in preparation for submissions, helping manufacturers reduce time-to-market for their products. By automating repetitive tasks and ensuring consistency across regulatory documents, the platform allows teams to focus on higher-value activities, ultimately driving greater efficiency and innovation within the organization.
 
“Fern.ai’s Smart Authoring module represents a significant leap forward for the medical device industry,” RQM+ CEO John Potthoff said. “By harnessing the power of AI and automation, we’re not only simplifying the creation, management, and maintenance of regulatory documentation but more importantly, it enables manufacturers to bring life-saving devices to market faster and with greater confidence. This platform is a game-changer for regulatory affairs professionals and the medtech industry as a whole.”
 
With the launch of Fern.ai’s Smart Authoring module, RQM+ reaffirms its commitment to innovation and excellence as a medtech service provider. Based on the proven AI expertise of our instrumental development partner Giotto.ai, the Smart Authoring module paves the way for a more efficient and compliant future in medtech.
 
RQM+ is a global medtech service provider focused on accelerating compliance and market success. Through its expertise and industry knowledge, the company delivers specialized solutions and expedites the journey along the full product lifecycle for medical device and IVD companies, from concept to commercialization to post-market. RQM+’s portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle through regulatory and quality consulting; lab services (Jordi Labs); clinical trials; reimbursement; and technology solutions.