The Compliance Intelligence
Platform for MedTech
Phablo transforms regulatory documentation into structured, traceable, and audit-ready intelligence across multiple frameworks.
Core Capabilities
What Phablo Does
Multi-Framework Gap Analysis
Analyze documents against EU MDR, IVDR, ISO standards, and expanding framework support.
- Identify missing and partial compliance
- Map clauses to document evidence
- Detect gaps across frameworks
- Suggest remediation actions
Pre-Submission Readiness Check
Evaluate whether documentation is ready for submission or notified body review.
- Identify missing or incomplete evidence
- Detect potential compliance risks
- Map requirements to supporting documentation
- Get a structured readiness overview
Technical Document Intelligence
Navigate large regulatory documents faster and find the evidence that matters.
- Extract document structure
- Contextual search across files
- Rapid evidence discovery
- Clause-level mapping
Human-in-the-Loop Validation
Keep experts fully in control of regulatory outcomes.
- Review AI-identified gaps
- Validate or reject findings
- Add comments and annotations
- Finalize compliance decisions
Multi-Document Compliance Analysis
Evaluate entire documentation sets together, including technical documentation, risk management files, clinical evaluation reports, SOPs, and validation materials.
- Analyze relationships across multiple documents
- Detect inconsistencies between related files
- Identify missing links between evidence sets
- Support full technical file assessments
Version Control and AI Comparison
Understand the compliance impact of document changes.
- Track document versions
- Identify meaningful regulatory changes
- Detect new compliance risks introduced
- Can be fast-tracked if required
Frameworks Supported
Phablo supports key MedTech and quality frameworks today, with broader coverage expanding over time.
Supported Today
Expanding Support
Built for Team-Based Compliance Workflows
Document Management
- Centralized repository
- Version-controlled storage
- Structured organization by product or project
Team and Collaboration
- Department-based access
- Regulatory team workflows
- Consulting collaboration support
Role-Based Access Control
- Secure document access
- Permission-based workflows
Audit Trail
- Trace document uploads and updates
- Track reviews and compliance decisions
- Maintain governance-ready history
Security, Privacy & Data Residency
Phablo is built for regulated environments where data protection, controlled access, and regional deployment considerations matter. We are designing the platform to support secure handling of sensitive regulatory documentation across EU and US customer needs.
Regional Data Residency
Designed to support region-aware deployment and data residency needs, including EU and US customer requirements where applicable.
Secure Document Handling
Sensitive regulatory and technical documentation is handled with controlled access, secure storage patterns, and strong protection measures.
Role-Based Access Control
Access to documents and workflows can be restricted by user role, helping teams manage permissions across functions and projects.
Auditability & Traceability
Document activity, review actions, and compliance decisions are tracked to support transparent and defensible workflows.
Data Protection by Design
The platform is built with security and privacy considerations integrated into core workflows, infrastructure decisions, and product design.
Aligned with Regulated Environments
We are building Phablo in line with the expectations of regulated industries, with ongoing focus on strengthening security posture as we scale.
We continue to strengthen our platform architecture and operational controls to support the security, privacy, and regional requirements of global MedTech teams.
More Than Document Storage.
Built for Regulatory Intelligence.
Phablo is not just a place to store files. It is a compliance intelligence platform that helps regulatory teams connect requirements, evidence, decisions, and readiness in one structured workflow.
Built to support regulatory experts — not replace them.