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.
Prepare and validate UDI device registrations for Swissdamed and EUDAMED submissions. Import from Excel or XML, edit device data in the browser, validate against the official XSD schemas, and export compliant XML ready to upload.
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.