Related Products
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About
Bluenote is an agentic AI software designed to help life sciences companies accelerate their regulatory submissions and documentation workflows, boosting productivity by automating critical tasks with enterprise-grade security and proven accuracy. It generates first drafts of scientific, clinical, and regulatory documents instantly, aligned with templates, standard operating procedures, and global guidelines, with built-in verification and traceability. It includes an AI assistant to refine data presentations, format datasets and tables, write figure captions, and run gap analyses. Bluenote’s workflow builder and specialized agents automate repetitive, multi-step processes so scientists and subject matter experts can focus on innovation, and its search tools let users explore internal datasets quickly to surface insights and reduce duplication. It also offers translation of technical and regulatory content while preserving formatting and glossary use.
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About
Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Life sciences professionals and organizations that need to automate and accelerate regulatory document creation and workflow processes with advanced AI tools
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Audience
Medical companies, regulatory consultants
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
Credit-based system
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationBluenote
Founded: 2022
United States
www.bluenotehealth.com
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Company InformationCruxi
Founded: 2024
United States
cruxi.ai
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Categories |
Categories |
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Integrations
No info available.
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Integrations
No info available.
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