Guideways

Guideways provides a platform of specialized AI agents designed to automate regulatory research, documentation, and compliance reviews for the medical device industry. The system assists MedTech startups, established companies, and consultants in navigating FDA, MDR, and IVDR requirements by generating structured drafts, identifying predicates, and performing gap analysis on submissions. It utilizes a curated database of over 1.6 million regulatory references to provide traceable, evidence-based pathways for clinical approval.