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Technology that speeds up medtech approvals & compliance

Comprehensive regulatory knowledge base, expert AI reasoning, and multi-step review logic for medtech devices and digital health solutions. 

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Guideways combines a curated regulatory knowledge base, task-specific workflows, and compliance checks. The goal is to support classification, pathway analysis, requirement mapping, and submission reviews in a way your Product team can understand and explain.

Guideways provides an integrated, AI-powered, platform purpose built for medtech regulatory & compliance processes 

When you use Guideways, you remain fully in control over interpretation and decisions. Guideways handles the structured, evidence-backed analysis behind them. All of this happens on a single underlying platform.

Reference content prepared for analysis

Guideways works on a comprehensive set of reference regulatory data:

  • Regulations for medical devices and software
  • Guidance documents and recognized standards
  • Device classifications, product codes, and reference devices
  • Selected approval information and related reference material
  • Your draft submission documents

This means queries run on cleaned, structured and continuously maintained data. Links between devices, codes, and requirements are clearer. Results stay focused on the device and indication you are working on. You see the source documents and citations.

Automates complex domain specific work

Guideways breaks regulatory work into focused tasks handled by specialized agents. Each one applies expert-level reasoning against regulatory guidelines to deliver deep, evidence-backed analysis your team can review and use.

  • Early scoping: Turn your device description into classification and pathway options, with mapped requirements and source-linked rationale
  • Deep research: Find and summarize relevant guidance, precedents, and supporting evidence, with citations you can trace
  • Pre-submission review: Check your documentation against requirements and flag gaps, inconsistencies, and missing evidence before you submit

You can inspect intermediate steps, not only the final answer.

Transparent reasoning to underpin decisions

Guideways checks your documentation against mapped requirements and turns findings into a clear, actionable review.

  • Compares your documents to identified requirements
  • Flags missing content, inconsistencies, and weak or incomplete support
  • Summarize issues in a submission-readiness view with clear items to address
  • Provides actionable recommendations to fix gaps

For each issue you see the requirement, the documents or sections affected, and how the conclusion was reached. This becomes a structured starting point for internal review and correction.

Fit for regulated teams

  • Data use: Your data is stored in our safe, private environment and is not used to train models.
  • Access control: Access to your data is secured through robust identity management with multi-factor authentication
  • Data Residency & Sovereignty: Your data is stored and processed in EU
  • Integration: Outputs can be exported and attached to your QMS, document management, or project tools.
  • Confidentiality: Your data remains private and is not used to train AI models.

Request a live Guideways demo.

 

In a 30-minute session, we show how Guideways supports product and regulatory teams in day-to-day regulatory and compliance work. Starting from a device description and intended use, the platform suggests classification and pathway options with a traceable rationale, maps the applicable regulations, guidances, and standards, and surfaces relevant precedents with linked sources. We also run a in-depth reviews of your submission documentation against mapped regulatory requirements.

You see each step, the references used, and the outputs generated, so you can clearly assess how Guideways fits into your existing regulatory process.

Get a demo