Complizen

What Complizen does

Complizen is an AI workspace designed for FDA medical device compliance, helping regulatory professionals, consultants, and manufacturers streamline their workflows. It transforms weeks of navigating guidance documents, product codes, predicates, and safety databases into clear regulatory assessments in under 30 minutes. The platform provides AI-powered FDA intelligence for research and drafting, with every step backed by FDA sources. It offers end-to-end coverage from classification through post-market, with collaborative tools, centralized version history, and automated project dashboards. Complizen also provides AI-accelerated FDA regulatory services, including 510(k) submission building and regulatory strategy, supported by ex-FDA regulatory experts. The platform is built with enterprise-grade security and privacy, including AES-256 encryption, TLS 1.3, SOC 2 aligned controls, and a commitment that customer data is never used to train AI models.

Products

• SuperagentAn AI FDA expert that dispatches specialized subagents to find, reason, and act on regulatory questions, returning cited and defensible answers.
• Drafting StudioAI-assisted document writing tool that helps create regulatory documents from templates, uploaded drafts, or from scratch, filling gaps and tracing citations.
• Submission BuilderA tool that drafts eSTAR sections from a device profile, runs RTA pre-flight checks, and exports a portal-ready package for 510(k) submissions.
• KnowledgeA unified, searchable database of every FDA database, guidance document, and international standard, with in-product citations.
• CollaborationFeatures for multiplayer document editing, shared Superagent threads, external consultant access, and a full audit trail.
• CloudSecure storage for documents and revisions, with AES-256, SOC 2, 21 CFR Part 11 compliance, role-gated access, and full audit trail.
• 510(k) Submission Building ServiceA service combining the Complizen platform with an ex-FDA regulatory team to accelerate 510(k) clearance, including AI drafting and expert review.
• Regulatory Strategy ServiceA service where Complizen's AI builds a regulatory strategy (pathway, predicate shortlist, requirements map, risk gaps) and a senior FDA expert reviews and refines it.
• Regulatory AdvisoryAn ongoing retainer service that pairs the Complizen platform with senior FDA expert hours for continuous, AI-accelerated guidance across all development stages.
• Complizen LearnAn open regulatory library offering guides, calculators, educational content, explainers, glossary, FDA tracker, templates, interactive tools, and learning paths.

Key capabilities

• AI-powered FDA intelligence
• Regulatory strategy automation
• Predicate analysis
• Risk intelligence
• Document drafting
• AI queries
• Project management
• Real-time collaboration
• Version history
• Submission Builder (eSTAR export)
• Enterprise-grade security & privacy (AES-256, TLS 1.3, SOC 2 aligned)
• Zero training on customer data
• SSO & MFA
• Audit logs
• Device classification
• Special controls & FDA guidance surfacing
• Submission pathway & user fee identification
• Defensible rationale document generation
• Deep 510(k) database search with AI-powered similarity scoring
• De Novo precedent search
• Competitive intelligence (market landscape)
• PMA precedent research
• Predicate risk history (MAUDE adverse events and recalls)
• Export-ready comparison tables
• Specialized subagents for regulatory tasks
• AI-assisted document writing with citation tracing
• RTA pre-flight checks for eSTAR submissions
• Unified FDA databases and standards
• Secure storage with role-gated access
• ISO 14971 compliance for risk management
• Hazard identification & analysis seeded from MAUDE history
• Risk-control traceability matrix
• FMEA (Failure Mode and Effects Analysis)
• Residual risk justification
• Risk Management Report generation
• Post-market surveillance links
• Automated requirement analysis
• Full submission traceability
• Hybrid editing with inline AI assistance
• Template library for regulatory documents

Use cases

• Regulatory strategy development
• Device classification
• Predicate research and analysis
• 510(k) submission building
• De Novo pathway identification
• PMA precedent research
• Risk management (ISO 14971)
• Drafting regulatory documents (e.g., Indications for Use, SE Narrative, RMP)
• Responding to FDA AI letters
• Auditing draft submissions
• Post-market surveillance monitoring
• Quality Management Systems & compliance
• Product engineering & design controls
• Validation testing
• Operations & vendor management
• Compliance & quality system training

AI approach

Complizen uses AI agents to process and analyze FDA data, guidance documents, and user-provided information to generate regulatory assessments, draft documents, and provide strategic recommendations for medical device compliance. The AI is designed to be transparent, citing all sources, and does not use customer data for model training. It employs specialized subagents for different regulatory tasks.

Tech named: AI agents, Superagent, specialized subagents, machine learning

Industries served

• Medical Devices
• Medtech

What it says sets it apart

• AI designed specifically for med-device regulatory affairs
• Every AI answer traces back to FDA guidance, 510(k) history, MAUDE, classification database, or user documents
• End-to-end coverage from classification through post-market in one workspace
• Purpose-built for medical devices, not a generic legal AI
• Customer data is never used to train AI models
• Significant time savings (200+ hours saved per submission, 340+ hours saved per submission on average)
• High RTA pass rate (94%) on submissions built and reviewed in Complizen
• Fixed-fee services with ex-FDA regulatory expert review
• Comprehensive security and compliance (SOC 2 aligned, AES-256, TLS 1.3, 21 CFR Part 11-style)
• Ability to accommodate more clients for consultants
• Clear regulatory assessment in under 30 minutes
• Offers both platform access and AI-accelerated services with expert involvement
• Provides a full audit trail for all actions and changes