From Documents to
Defensible Compliance.
Phablo transforms regulatory documents into structured, traceable, and audit-ready compliance intelligence — powered by AI, validated by experts.
Built for MedTech teams working with EU MDR, EU IVDR, ISO 13485, and ISO 14971, with FDA support expanding and more frameworks coming soon.
Most compliance issues don't come from missing documents.
They come from missing proof, broken traceability, fragmented evidence, and gaps discovered too late. Phablo helps teams identify and address compliance issues before audits and submissions begin.
Why compliance still breaks — even when everything looks complete
Traceability fails during audits
Documents exist, but traceability fails during audits.
Fragmented evidence
Evidence is spread across disconnected files.
Manual gap analysis
Gap analysis is manual, slow, and inconsistent.
Issues found too late
Issues are discovered too late during submission or review.
AI Gap Analysis That Actually Holds Up in Audits
Phablo analyzes regulatory and technical documents against multiple frameworks and helps identify the gaps that matter.
How It Works
Three Steps to Audit-Ready Compliance
01. Upload
Upload Your Documents
Technical files, SOPs, CER, risk documentation, and other compliance documents in one place.
Don't Find Gaps During Review. Find Them Before.
Phablo helps evaluate whether documentation is truly ready for submission by identifying missing evidence, weak sections, and potential review risks early.
Focused on EU MDR, EU IVDR, and ISO workflows today, with FDA support expanding and more frameworks coming soon.
Built for Real Regulatory Workflows
Evidence, not just documents
Map regulatory requirements directly to supporting proof.
Human-in-the-loop by design
Experts validate every output to keep decisions defensible.
Multi-framework from day one
Support for EU MDR, IVDR, ISO 13485, and ISO 14971, with more coming soon.
Built for MedTech
Purpose-built for regulated product and quality workflows, not generic AI tasks.
What Teams Get With Phablo
Faster Reviews
Reduce weeks of manual analysis to days.
Audit Readiness
Ensure traceability before audits begin.
Fewer Surprises
Catch gaps earlier, not during submission.
Better Decisions
Get clear visibility into compliance status.
AI Where It Helps. Humans Where It Matters.
Phablo is designed to support regulatory experts, not replace them.
Be Ready Before the Audit — Not During It.
See how Phablo helps MedTech teams move from documentation to structured, defensible compliance.