Review Documentation Faster with AI-Powered Pre-Screening
Focus your expertise where it matters most. Let AI handle exhaustive requirement checking while you make the critical judgments.
Modular Capabilities
RegCheck is a modular platform—use the capabilities you need, when you need them.
Regulatory Pathway Analysis
AI analyzes product information to determine device classification, applicable regulatory pathway, and relevant requirements.
Documentation Pre-Screening
Exhaustive requirement checking against thousands of regulatory requirements—not just samples.
Consistent Standards Application
AI applies the same rigorous checks every time—no variability between reviewers or fatigue-related oversights.
Transparent Audit Trail
Every AI judgment includes reference files and explanatory text. Full traceability for your records.
Continuous Learning
The platform learns from feedback, building a knowledge pool that improves over time with your expertise.
AI Augments Your Expertise
RegCheck doesn't replace auditors and reviewers—it amplifies your capabilities. Final certification decisions always remain with you.
Manufacturers Submit
Companies use RegCheck to pre-screen their documentation before formal submission.
AI Pre-Screens
Exhaustive requirement checking identifies gaps and inconsistencies automatically.
You Receive Better Submissions
Documentation arrives more complete, reducing revision cycles and speeding certification.
Interested in Partnering?
We're working with Notified Bodies and audit authorities to streamline the certification process. Let's discuss how RegCheck can support your work.
Get in Touch