RQM+ has introduced the AI-powered Fern.ai Smart Authoring module, a significant addition to its Fern.ai platform, aimed at redefining regulatory documentation in the medtech sector.

This platform now includes Smart Authoring and Systematic Literature Review.

The new module is intended to improve compliance, accuracy, and efficiency in creating and managing regulatory documents.

Offering a groundbreaking solution to the complexities of regulatory documentation, the Fern.ai Smart Authoring module helps automate and streamline the creation, management, and maintenance of these critical documents, ensuring readiness for regulatory submissions.

RQM+ collaborated with AI technology company Giotto.ai in developing the Smart Authoring module.

The module’s main features include smart keys and product profiles to provide a single source of truth for document version control; template management and alignment; dynamic linking across documents; enhanced team collaboration; and streamlined literature reviews.

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These capabilities are designed to reduce time-to-market for medtech products by accelerating document preparation.

RQM+ CEO John Potthoff said: “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.”

RQM+ said that the AI-driven platform minimises repetitive tasks and promotes consistency, allowing teams to concentrate on strategic activities that drive innovation and efficiency.