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From Concept To Clinical use
Expert-level AI for medtech approval & compliance
Guideways’ AI agents gives medtech teams instant, expert-level, structured and traceable answers to classification, pathways, standards and submission readiness.
Your guided route to medtech approval starts here.
✓ FDA
✓ MDR
✓ IVDR
✓ QMS
Innovative teams across medtech face the same pressure. Regulatory expertise is scarce and costly. Internal capacity is limited. Approval timelines stretch from months into years with no clear reason why. Every delay forces rework, diverts R&D time and increases cost. Most tools solve only isolated tasks while regulations shift faster than teams can track.
The result? Slow progress, late surprises and substantial delays leaving patients waiting for life-changing innovations.
Move with confidence rather than uncertainty.
Guideways acts as your expert regulatory guide, giving you evidence based insight the moment you describe your product.
The platform combines a curated regulatory knowledge base with multi-agent reasoning systems. Together they deliver clear pathways, validated requirements and expert submission reviews without waiting for external capacity or navigating thousands of documents.
Clarity
Faster understanding of classification, predicates and pathways.
Predictability
Earlier insight into approval requirements enables more reliable planning and fewer late surprises.
Autonomy
Teams progress without constant reliance on scarce and expensive external expertise.
Efficiency
Lower regulatory effort per product through automation of complex research and review tasks.
Assurance
Outputs are backed by traceable regulatory evidence and structured expert-level reasoning.
Capacity
Scalable regulatory support expands output while freeing experts for the most strategic tasks.
Deeply specialized AI agents that support the full route to clinical use
Sherpa
Your starting point for classification, predicates, pathways, guidances, standards and controls. Sherpa turns a plain-language device description into an underpinned regulatory strategy.
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Reviewer
Reviewer helps you find gaps and inconsistencies in regulatory submissions before regulators do, reducing the risk of delays, questions and rework.
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Drafter
Drafter generates structured first drafts of key CE and FDA documents using your device information and regulatory context.
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Researcher
Researcher delivers deep, evidence-backed regulatory answers without the need to manually search and cross-reference dozens of documents.
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“We experience a lack of solutions to enable small and innovative teams to get regulatory approval.
A solution like Guideways is an instant buy for us to accelerate our product portfolio.”
Who uses Guideways?
Startups & Scaleups
Get early regulatory clarity and a credible plan for investors. Move without depending on scarce experts.
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MedTech Companies
Support internal, overloaded regulatory teams with scalable intelligence. Reduce waiting times and rework.
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Consultants
Seamlessly scale your business to handle more engagements and complex work without impacting quality.
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Each group follows a different path but faces the same bottlenecks. Guideways helps them all move forward.
Evidence based reasoning is built into the system. Every pathway, requirement and review step includes traceable references from the underlying regulatory dataset. Pilot users report faster clarity, fewer revisions and higher confidence in planning.
In my test of a recent submission, Guideways' Reviewer AI identified the same key findings as the FDA and even highlighted a few additional helpful improvement points.
Charusheila Ramkumar
Independent Consultant & Chief Science Officer, Cntrl+ Inc
It took me 30 minutes to create a comprehensive MDR certification assessment with Guideways. This took us a whole month before.
Maickel Koenders
Compliance Officer, Archi Healthcare
Using Guideways’ FDA Sherpa helped us quickly define our intended use and map out the right FDA pathway for our next-generation vascular surgery robot. It not only saved time but also explained the reasoning behind its recommendations; something that really built confidence to navigate complex regulations.
Saskia ten Siethoff
QA/RA Specialist, Flux Robotics
I routinely review regulatory precedent for early-stage companies. Guideways has automated this process, quickly analysing suitable product codes and predicates which I can review in detail when formulating the overall regulatory strategy. Guideways saves me time and I feel confident in the results (vs general AI which routinely hallucinates codes and devices).
Liz Munro
Liz Munro Consulting
As a MedTech company, regulatory requirements have an enormous impact on our strategy and road to market. Guideways made it easy and accessible for us to quickly assess where we stand and how to proceed.
Martijn van de Giessen
Founder & CEO, Secuped
We experience a lack of solutions to enable small and innovative teams to get regulatory approval. A solution like Guideways is an instant buy for us to accelerate our product portfolio.
Marcel Alberti
CEO & Co-Founder, Coforix AI
Guideways is powered by:
Expert reasoning & workflows
Deeply specialized AI agents that perform expert reasoning and complex multi-step tasks.
1.6M+ regulatory references
Curated regulations, guidances, standards and submissions from FDA and MDR/IVDR.
Multi-model & multi-modal
Models are specialized and combined for depth, stability, and consistency.
Transparent and grounded
Results include references to underlying regulatory sources.
Safe & confidential
Data is protected and not used for training AI models.