Comprehensive gap analysis for EU MDR, FDA pathways, and international standards. Our AI analyzes your technical documentation against applicable requirements.
European Medical Device Regulation for all medical devices marketed in the EU. Covers classification, conformity assessment, clinical evaluation, and post-market surveillance requirements.
European In Vitro Diagnostic Medical Devices Regulation. Applies to reagents, instruments, and systems intended for in vitro examination.
Premarket notification for devices that are substantially equivalent to a legally marketed predicate device. Required for most Class II devices.
Premarket Approval for Class III devices. The most stringent type of device marketing application, requiring clinical studies to demonstrate safety and effectiveness.
Classification pathway for novel low-to-moderate risk devices with no legally marketed predicate. Creates a new classification for future 510(k) submissions.
International standard for quality management systems specific to medical devices. Forms the foundation for regulatory compliance worldwide.
AI-powered review of your technical file against regulatory requirements. Identifies missing sections, incomplete data, and compliance gaps.
Analysis of clinical evaluation reports, literature reviews, and clinical investigation data against regulatory expectations.
For 510(k) submissions, our AI helps analyze substantial equivalence arguments and identifies potential weaknesses.
Assessment of risk management files against ISO 14971 requirements and regulatory expectations.
Upload your technical documentation and receive a comprehensive gap analysis within minutes. Identify compliance issues before they delay your submission.