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Introducing Everest

Simplify Regulatory Submissions

Equip your team with AI that generates regulatory-ready documentation—tailored to your workflow and built to meet FDA requirements and best practices.

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Struggling with complex regulations and time-consuming documentation for regulatory submissions? A smarter, workflow-aware solution is needed.

The old way

Manually build documents.

Ready in days to weeks

The Everest way

Let AI generate documents.

Ready in minutes

Goodbye guesswork.
Hello AI precision.

Goodbye guesswork. Hello AI precision.

Get things done quicker with AI that generates accurate, regulatory-compliant documentation—tailored to your workflow and responsive to your evolving needs.

Your submission, mapped out.

Provide key details and let Everest deliver a clear, step-by-step roadmap for every required document.

Fast, accurate documents.

Choose or create a template, upload unlimited sources, and receive a polished draft in minutes. Collaborate seamlessly and publish with ease.

Get it right the first time.

Everest understands FDA requirements, ensuring your documents are compliant from the outset—eliminating costly rework.

How it works

The fast track to FDA-compliant documents.
Get started in minutes.

1

Select a template

Start with a preconfigured template, derive an outline from a reference file, or design your own layout from scratch.

2

Upload docs, reports, and data

Select diverse files (rich PDFs, graphs, tables, etc.) from multiple sources to give Everest the information it needs.

3

Generate and edit drafts

Everest compiles a comprehensive draft in minutes—summarizing your uploaded content with citations—so your team can collaborate to finalize the document.

4

Publish and iterate

Publish your document—each team edit trains Everest’s AI for even greater accuracy and compliance in future iterations.

1

Select a template

Start with a preconfigured template, derive an outline from a reference file, or design your own layout from scratch.

2

Upload docs, reports, and data

Select diverse files (rich PDFs, graphs, tables, etc.) from multiple sources to give Everest the information it needs.

3

Generate and edit drafts

Everest compiles a comprehensive draft in minutes—summarizing your uploaded content with citations—so your team can collaborate to finalize the document.

4

Publish and iterate

Publish your document—each team edit trains Everest’s AI for even greater accuracy and compliance in future iterations.

1

Select a template

Start with a preconfigured template, derive an outline from a reference file, or design your own layout from scratch.

2

Upload docs, reports, and data

Select diverse files (rich PDFs, graphs, tables, etc.) from multiple sources to give Everest the information it needs.

3

Generate and edit drafts

Everest compiles a comprehensive draft in minutes—summarizing your uploaded content with citations—so your team can collaborate to finalize the document.

4

Publish and iterate

Publish your document—each team edit trains Everest’s AI for even greater accuracy and compliance in future iterations.

AI to speed up your regulatory journey.

From pre-market to post-market, let Everest deliver accurate, regulation-ready docs that cut your time to market and reduce expenses.

510(k) Submissions

Additional Information (AI)

Device Updates

510(k) Submissions

Accelerate your 510(k) submission

Build your eSTAR roadmap, generate instant section drafts, refine with teammates, and get compliance right the first time. Everest covers every step to accelerate your submission.

Chart your course

Supply essential device details and let Everest build an optimal 510(k) eSTAR roadmap that defines every necessary section and document for your submission.

Instant drafts

In minutes, Everest uses AI-driven templates to merge your source docs and data with the latest FDA regulations, delivering accurate section drafts.

Edit, review, and submit

Refine each section as a team, then when final, upload directly to eSTAR. Everest learns from every edit to improve your documents over time.

Smart compliance, rapid clearance

Everest uses proven best practices to meet FDA guidelines, boosting clearance odds and accelerating market entry.

510(k) Submissions

Additional Information (AI)

Device Updates

510(k) Submissions

Accelerate your 510(k) submission

Build your eSTAR roadmap, generate instant section drafts, refine with teammates, and get compliance right the first time. Everest covers every step to accelerate your submission.

Chart your course

Supply essential device details and let Everest build an optimal 510(k) eSTAR roadmap that defines every necessary section and document for your submission.

Instant drafts

In minutes, Everest uses AI-driven templates to merge your source docs and data with the latest FDA regulations, delivering accurate section drafts.

Edit, review, and submit

Refine each section as a team, then when final, upload directly to eSTAR. Everest learns from every edit to improve your documents over time.

Smart compliance, rapid clearance

Everest uses proven best practices to meet FDA guidelines, boosting clearance odds and accelerating market entry.

510(k) Submissions

Accelerate your 510(k) submission

Build your eSTAR roadmap, generate instant section drafts, refine with teammates, and get compliance right the first time. Everest covers every step to accelerate your submission.

Chart your course

Supply essential device details and let Everest build an optimal 510(k) eSTAR roadmap that defines every necessary section and document for your submission.

Instant drafts

In minutes, Everest uses AI-driven templates to merge your source docs and data with the latest FDA regulations, delivering accurate section drafts.

Edit, review, and submit

Refine each section as a team, then when final, upload directly to eSTAR. Everest learns from every edit to improve your documents over time.

Smart compliance, rapid clearance

Everest uses proven best practices to meet FDA guidelines, boosting clearance odds and accelerating market entry.

Additional Information (AI)

Fast-Track your Additional Information (AI) response

Everest’s swift, AI-driven responses to FDA Additional Information requests keep your submission on track—accelerating your 510(k) clearance.

Map your response

Everest analyzes the FDA deficiency email and PDF, generating a project plan that organizes the requested information.

Instant Drafts

Generate draft documents in minutes using AI-driven templates and your data.

Edit, review, and reply

Collaborate to refine your documents, then seamlessly submit your final response package.

Best-practice compliance

Everest leverages proven best practices to meet FDA guidelines, boosting clearance odds and accelerating market entry.

Device Updates

Streamline documentation of software updates

From impact analysis to final submission, Everest automates your software update documentation process, keeping your device seamlessly compliant with FDA requirements.

Detect required updates

Everest analyzes every software change to determine its impact and automatically triggers documentation updates according to FDA guidelines.

Instant drafts

Generate comprehensive draft documents in minutes with AI that leverages your previous documentation and current change data.

Collaborative refinement

Work together to fine-tune your document, then seamlessly submit the final version.

Effortless compliance

Everest ensures updates meets the latest FDA guidelines and industry standards, minimizing the risk of non-compliance and audit issues.

FDA submissions, powered by next-gen AI

Everest seamlessly integrates with your systems to automate FDA submissions, regulatory compliance, and medical writing—from 510(k) submissions to software update documentation—speeding up clearance and improving quality management.

A platform you
can trust.

A platform you can trust.

A platform you can trust.

Everest puts you in full control of your data while ensuring privacy and security, so teams can focus on bringing life-changing products to market.

Data ownership

Your data is yours—always. Our platform gives you complete control, never sharing, selling, or accessing your information without your express consent, so you always know your data is safe.

Data privacy

We protect your data with advanced encryption, strict access controls, and robust security measures. Customizable anonymization and retention policies let you manage your data’s lifecycle exactly the way you want.

Data security

Our platform is built to securely handle sensitive medical information in line with BAA requirements. With advanced encryption and secure processing, we keep your data safe while delivering reliable, compliant documents.

Learn how we can simplify regulatory submissions.

Schedule a demo and see how Everest transforms complex filings into an efficient, streamlined workflow.

Chart your step-by-step submission roadmap.

Generate comprehensive drafts in minutes.

Collaborate with teammates to perfect & submit.

Achieve FDA-complaint documents from day one.

Schedule a demo

© Copyright 2025 Log10, Inc. All rights reserved.

Learn how we can simplify regulatory submissions.

Schedule a demo and see how Everest transforms complex filings into an efficient, streamlined workflow.

Chart your step-by-step submission roadmap.

Generate comprehensive drafts in minutes.

Collaborate with teammates to perfect & submit.

Achieve FDA-complaint documents from day one.

Schedule a demo

© Copyright 2025 Log10, Inc. All rights reserved.

Learn how we can simplify regulatory submissions.

Schedule a demo and see how Everest transforms complex filings into an efficient, streamlined workflow.

Chart your step-by-step submission roadmap.

Generate comprehensive drafts in minutes.

Collaborate with teammates to perfect & submit.

Achieve FDA-complaint documents from day one.

Schedule a demo

© Copyright 2025 Log10, Inc. All rights reserved.