RegCheck is an AI‑native compliance platform that automates the entire regulatory workflow for highly regulated industries. It ingests product and regulatory documents, performs rapid gap analyses, and continuously learns from each file to improve detection accuracy and reduce audit‑related costs.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated companies often rely on manual document searches and manual cross‑referencing to ensure products meet complex regulatory standards, leading to slow gap analyses, missed critical issues, and high costs from audit failures.
Solution
RegCheck provides an AI‑native compliance platform that automates the entire compliance workflow. The system ingests regulatory documents, product files, and prior review data to perform rapid gap analyses, delivering initial results in hours instead of weeks. Its machine‑learning engine continuously learns from each processed file, improving detection accuracy from 82% on the first file to over 94% after calibration, and eliminating repeat mistakes. The platform integrates with existing enterprise systems, aligns with notified‑body expectations, and maintains ISO 27001‑certified security, enabling compliance teams to work faster, more precisely, and at lower cost.
Target Audience
RegCheck targets compliance, regulatory affairs, and quality assurance teams within highly regulated industries such as medical devices, pharmaceuticals, and aerospace that need to streamline product approvals and audit preparation.
Features
- AI‑driven gap detection that identifies regulatory gaps with 82% accuracy on first use, improving to 94% after system calibration
- Automated ingestion and cross‑referencing of regulatory documents, product specifications, and prior review histories
- Continuous learning engine that refines terminology, product portfolio knowledge, and regulatory expectations with each processed file
- Seamless integration with enterprise systems and notified‑body workflows for end‑to‑end compliance orchestration
- ISO 27001‑certified security and Swiss‑made infrastructure ensuring data protection and reliability
- Dashboard for real‑time gap reporting, audit readiness tracking, and actionable remediation guidance