phablo.ai is an AI-native compliance intelligence platform built for MedTech companies operating under strict regulatory frameworks such as EU MDR/IVDR, FDA QMSR and ISO standards.
We provide an AI-native SaaS platform acting as a unified compliance engine that connects Quality Assurance and Regulatory Affairs workflows into a single, traceable system.
phablo automates regulatory GAP analysis, document review, evidence structuring and audit preparation across ISO 13485, ISO 14971, EU MDR/IVDR and FDA QMSR.
The platform operates as a non-disruptive layer on top of existing systems, reducing manual effort, shortening review cycles and eliminating inconsistencies across teams while maintaining full auditability and governance.
Unlike traditional QMS or document management tools, phablo is AI-native and framework-agnostic. Our engine performs clause-by-clause analysis, detects compliance gaps and continuously aligns documentation with evolving regulatory requirements.
phablo acts as a single source of truth across QA, RA and R&D, enabling faster internal reviews, better audit readiness and higher confidence in regulatory decision-making without compromising governance or traceability.
phablo is developed and validated in close collaboration with MedTech manufacturers, compliance experts and regulatory advisors across Europe, the US and Africa, ensuring applicability in real-world, enterprise-grade regulatory environments.