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Researcher

Deep regulatory research with evidence-backed reasoning.

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✓ FDA

✓ MDR

✓ IVDR

✓ QMS

Researcher automates deep regulatory research work on top of a knowledge base of more than 1,6M regulatory documents, including  regulations, guidance documents, product codes, and approvals. Specialized agents and multiple models run evidence searches, extract relevant information, and present reasoning steps backed by regulatory sources.

Simply ask your regulatory search questions and receive evidence-backed answers. Researcher accelerates complex regulatory research while preserving confidence.

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Structured regulatory intelligence

Consolidates regulations, guidances, standards, codes, and approvals.

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Deep multi-agent architecture

Specialized agents working together to research documents across multiple databases.

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Multi-document workflows

Built for regulatory research that crosses multiple documents and sources.

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Evidence backed outputs

Results you can review, challenge, and reuse in your own deliverables.

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Made to reduce manual research

Replaces long document sessions with targeted, structured findings.

Pathway Specific Features 

✓ 21 CFR & USC Title 21 regulation review

✓ FDA guidance review

✓ Product code search

✓ 510k & DeNovo device search

✓ PMA and HDE device search

✓ Recognized Consensus Standards search

✓ MAUDE adverse event search

Get underpinned assessments that seamlessly support your key regulatory decisions and responses to authorities.

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Who can benefit from Guideways.ai?

Startups & Scaleups

Built to give you expert-level regulatory intelligence you don’t have in-house.

 

  • Expert insight on demand
  • Evidence you can cite
  • Stronger internal decisions

MedTech Companies

Built to provide scalable support when teams are at full capacity and reduce errors.

 

  • Scalable support on demand
  • Fewer avoidable errors
  • Faster submission prep

Regulatory Consultants

Automates deep research steps and increases throughput per consultant.

 

  • Higher throughput per consultant
  • Less manual research
  • More reliable execution

Each group follows a different path but faces the same bottlenecks. Guideways helps them all move forward.

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