Confinis leverages artificial intelligence to streamline regulatory affairs and quality management processes for medical device and pharmaceutical manufacturers. Beyond is our initiative to transform how RA/QA work gets done—faster, smarter, and with greater precision.
Perform precise, auditable line-by-line comparisons of regulatory documents between versions or jurisdictions. Identify additions, deletions, and editorial changes with color-coded clarity.
Automatically verify whether regulatory documents in your standard list are current and up-to-date. Save hours of manual checking with intelligent version monitoring across all your documentation.
Streamline your PSUR updates with AI-powered safety database analysis. Automatically assess relevance, classify adverse events, and generate structured reports from MAUDE, BfArM, ANSM, and more.
Conduct systematic literature reviews for clinical evaluations with an AI-driven 6-step workflow. From reference import and deduplication to abstract and full-text appraisal, generate PRISMA-compliant evidence tables automatically.