Manages regulatory compliance documentation
Giotto Compliance is an AI-powered platform developed for the medical device and in-vitro diagnostics sectors, designed to streamline the regulatory compliance process. It simplifies the creation, analysis, and management of clinical evaluation reports (CERs), essential for regulatory submissions under frameworks like the EU Medical Device Regulation (MDR). Acquired by RQM+, Giotto Compliance uses automation to handle data collection, screening, and report generation, allowing regulatory teams to reduce manual workloads and improve documentation accuracy. The tool leverages artificial intelligence for various tasks, including data extraction, categorization, and document analysis, making it easier for regulatory professionals to ensure their products meet compliance standards efficiently.