Key Highlights
- Single Source of Truth: Smart Keys and product profiles ensure consistency with version control and common terminology.
- Template Management and Alignment: Automatically update content within product profiles and populate across templates.
- Dynamic Linking: Adapts to content changes, enabling collaboration across authors.
- Enhance Team Collaboration: Cross-functional access for comments and editing within the platform.
- Streamline Literature Reviews: Integrate outputs directly into product documentation.
Source: Business Wire
Notable Quote
- “Fern.ai’s Smart Authoring module represents a significant leap forward for the medical device industry. 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.” – John Potthoff, CEO at RQM+
SoHC's Take
The launch of Fern.ai’s Smart Authoring module by RQM+ is a pivotal moment for the MedTech industry. This innovative tool not only streamlines the creation and management of regulatory documentation but also ensures compliance and efficiency through advanced AI capabilities. By automating repetitive tasks and facilitating real-time collaboration, Smart Authoring significantly reduces time-to-market for medical devices, fostering greater innovation and confidence among manufacturers. As regulatory demands continue to grow, tools like Fern.ai are essential for maintaining accuracy and accelerating the approval process, ultimately benefiting the entire MedTech landscape.
