OpenRegulatory
Document Management & eSignature ToolsAn AI-powered, all-in-one eQMS for medical devices that consolidates regulatory documentation, quality processes, and cross-functional collaboration into a single platform, replacing scattered tools, PDFs, and manual spreadsheets with workflow-driven governance and solid audit trails.
Core features include real-time completeness checks, multi-format exports (DOCX, PDF, Markdown, HTML), audit-ready e-signatures compliant with 21 CFR Part 11, out-of-the-box ISO 13485 and EU MDR readiness, and pre-built templates mapped to ISO 13485, IEC 62304, ISO 14971, and IEC 62366, plus a free learning community for regulation education and peer support, designed for lean product teams, regulatory professionals, and quality managers to accelerate compliance and speed time-to-market.
OpenRegulatory can be found in Document Management & eSignature Tools categories.
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