Phablo

What Phablo does

Phablo is building AI-native compliance intelligence for MedTech and Life Sciences. The platform analyzes technical and clinical documentation against global regulatory frameworks such as EU MDR, IVDR, FDA, and ISO -enabling teams to identify gaps, interpret requirements, and prepare for audits, submissions, and certification reviews. With AI-driven gap analysis, guided remediation, and technical file intelligence, Phablo enables faster reviews, earlier risk detection, and more confident compliance outcomes. Phablo transforms fragmented documentation into a structured, defensible compliance layer, helping teams move innovations through regulatory pathways with greater clarity and speed. With operations across the EU and US, Phablo is built for global MedTech teams navigating MDR and FDA regulatory pathways. Phablo transforms regulatory documents into structured, traceable, and audit-ready compliance intelligence — powered by AI, validated by experts. It helps teams identify and address compliance issues before audits and submissions begin by mapping document sections to regulatory clauses automatically, identifying missing, partial, and weak evidence, detecting cross-framework inconsistencies, and providing structured remediation guidance. Phablo is designed to support regulatory experts, not replace them, allowing for review and validation of AI findings, approval or rejection of recommendations, and adding expert comments and annotations.

Key capabilities

• AI-driven gap analysis
• Guided remediation
• Technical file intelligence
• Analyzes regulatory and technical documents against multiple frameworks
• Maps document sections to regulatory clauses automatically
• Identifies missing, partial, and weak evidence
• Detects cross-framework inconsistencies
• Structured remediation guidance
• Validation workflows (human-in-the-loop)
• Full traceability from requirement to evidence
• Evaluates documentation readiness for submission
• Highlights sections likely to fail review
• Structured readiness overview
• Multi-framework from day one (EU MDR, IVDR, ISO 13485, ISO 14971, FDA expanding)
• Review and validate AI findings
• Approve or reject recommendations
• Add expert comments and annotations
• Multi-Framework Gap Analysis
• Pre-Submission Readiness Check
• Technical Document Intelligence
• Human-in-the-Loop Validation
• Multi-Document Compliance Analysis (Launching Soon)
• Version Control and AI Comparison (Launching Soon)
• Document Management (Centralized repository, Version-controlled storage, Structured organization)
• Team and Collaboration (Department-based access, Regulatory team workflows, Consulting collaboration support)
• Role-Based Access Control
• Audit Trail
• Security, Privacy & Data Residency (Region-aware deployment, Secure document handling, Data protection by design)

Use cases

• Identify gaps in technical and clinical documentation against regulatory frameworks
• Interpret regulatory requirements
• Prepare for audits, submissions, and certification reviews
• Identify and address compliance issues before audits and submissions
• Evaluate whether documentation is truly ready for submission
• Reduce delays, rework, and back-and-forth in compliance processes
• Ensure traceability before audits begin
• Catch compliance gaps earlier
• Gain clear visibility into compliance status
• Navigate large regulatory documents faster
• Find evidence within regulatory documents
• Evaluate entire documentation sets together
• Understand the compliance impact of document changes

AI approach

Phablo uses AI to analyze technical and clinical documentation against global regulatory frameworks (EU MDR, IVDR, FDA, ISO) to identify gaps, interpret requirements, and prepare for audits, submissions, and certification reviews. The platform provides AI-driven gap analysis, guided remediation, and technical file intelligence. It maps document sections to regulatory clauses automatically, identifies missing/partial/weak evidence, detects cross-framework inconsistencies, and offers structured remediation guidance. The approach is human-in-the-loop, where experts validate AI findings.

Tech named: AI-native compliance intelligence, AI-driven gap analysis, AI comparison

Industries served

• MedTech
• Life Sciences

What it says sets it apart

• AI-native compliance intelligence
• Transforms fragmented documentation into structured, defensible compliance layer
• AI-driven gap analysis with human-in-the-loop validation
• Purpose-built for regulated product and quality workflows in MedTech
• Multi-framework support from day one (EU MDR, IVDR, ISO 13485, ISO 14971, FDA expanding)
• Focus on evidence, not just documents
• Designed to support regulatory experts, not replace them
• Built for team-based compliance workflows
• Strong focus on security, privacy, and data residency for regulated environments
• Compliance becomes continuous, not periodic
• Evidence becomes structured, not scattered
• Scalable by design

Funding rounds we track

From the AI funding tracker — rounds as reported by the linked publications.