Guideways provides an AI‑driven platform that gives medical device teams instant, expert‑level regulatory guidance by turning plain‑language product descriptions into structured classifications, predicates, pathways, and required standards. Its multi‑agent system also reviews submission drafts to flag gaps and inconsistencies, delivering traceable, evidence‑backed recommendations that reduce reliance on external consultants and accelerate approval planning.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device companies often face lengthy, opaque regulatory approval processes that require extensive expertise, manual document review, and navigation of thousands of standards, leading to delays and costly uncertainties.
Solution
Guideways offers an AI-driven platform that delivers instant, expert-level regulatory guidance for medical technology products. Users input a plain-language description of their device, and specialized AI agents generate structured classifications, identify applicable predicates and pathways, and outline required standards and controls. The system also reviews submission drafts to highlight gaps and inconsistencies before regulators see them, reducing rework and surprise queries. All recommendations are backed by traceable regulatory evidence drawn from a curated knowledge base, enabling teams to plan with greater predictability and progress without relying on scarce external consultants.
Target Audience
Primary customers are medical device manufacturers, digital health startups, and regulatory affairs teams that need efficient, reliable guidance through the approval and compliance process.
Features
- Sherpa agent transforms device descriptions into detailed regulatory strategies, including classification, predicates, and applicable guidance documents
- Reviewer agent automatically scans submission drafts to detect missing information, inconsistencies, and potential regulatory objections
- Researcher agent provides evidence-backed answers by cross-referencing dozens of standards, regulations, and guidance sources
- Multi‑agent reasoning combines curated regulatory knowledge with AI inference to produce traceable, structured outputs
- Real‑time insight into approval requirements supports more reliable project planning and risk mitigation
- Cloud‑based interface accessible to internal teams, eliminating the need for external expert capacity