These Terms of Use ("Terms") govern your access to and use of SE.ai Workbench, including SE.ai's websites, applications, AI-powered regulatory tools, knowledge systems, reports, outputs, APIs, Koins, and related services (collectively, the "Service").
These Terms are entered into by and between you and SEAI Solutions, Inc., a Delaware corporation doing business as SE.ai, with its principal place of business in South Carolina ("SE.ai," "we," "us," or "our").
By creating an account, clicking "I agree," purchasing Koins, accessing the Service, or using the Service, you agree to be bound by these Terms. If you do not agree to these Terms, you must not use the Service.
If you use the Service on behalf of a company, organization, institution, consultancy, laboratory, or other legal entity, you represent and warrant that you have authority to bind that entity to these Terms, and "you" refers to that entity and its Authorized Users.
"Authorized User" means an individual who accesses or uses the Service on behalf of, under, or through an Organization Account.
"Consumer User" means an Individual User who is entitled to non-waivable consumer protection, privacy, or data protection rights under applicable law.
"Customer Content" means any content, data, prompts, queries, device descriptions, regulatory information, text, feedback, notes, messages, or other materials that you submit, enter, transmit, create, or otherwise provide to the Service, as well as outputs generated specifically for you based on your inputs, except for SE.ai Technology.
"Individual User" means a user who accesses or uses the Service for personal, independent, non-organizational, or non-enterprise purposes.
"Koins" means platform credits that may be used within the Service to access eligible workflows, features, reports, analyses, or other paid functions.
"Organization" means a company, startup, institution, consultancy, laboratory, research organization, regulatory affairs firm, CRO, testing organization, or other legal entity.
"Organization Account" means an account, workspace, or other Service environment created, paid for, administered, or controlled by an Organization.
"Personal Data" or "Personal Information" means information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked to an identified or identifiable individual, as defined by applicable law.
"SE.ai Technology" means the Service and all SE.ai-owned or SE.ai-licensed software, systems, workflows, interfaces, models, agents, prompts, configurations, algorithms, retrieval systems, evaluation frameworks, templates, documentation, trademarks, logos, and other technology or content, excluding Customer Content.
SE.ai Workbench is an AI-powered regulatory workflow platform designed to support medical device regulatory research, FDA 510(k) planning, predicate device analysis, substantial equivalence assessment, Q-Submission preparation support, document drafting support, knowledge management, and related regulatory workflow activities.
The Service may include tools such as FastMap™, Summary Enhancement Device (SED), Koinbase, AI agent assistance, regulatory knowledge systems, structured reports, comparison tables, risk matrices, draft documents, and other workflow outputs.
The Service is intended to assist regulatory research, evidence organization, drafting, and decision support. The Service does not replace qualified legal, regulatory, clinical, medical, engineering, quality-system, or other professional judgment.
You must be at least 18 years old to use the Service.
To access certain features, you may be required to create an account. You agree to provide accurate, current, and complete information and to keep such information updated.
You are responsible for maintaining the confidentiality of your login credentials and for all activity occurring under your account.
You must notify SE.ai promptly at [email protected] if you suspect unauthorized access to or use of your account.
SE.ai may refuse registration, suspend access, restrict features, or terminate accounts where SE.ai reasonably believes that doing so is necessary to protect the Service, other users, SE.ai, or third parties.
If you use the Service as an Individual User, you are personally responsible for your use of the Service, your Customer Content, your purchases, and your compliance with these Terms.
If you use the Service on behalf of an Organization, you represent and warrant that you have authority to bind that Organization to these Terms. The Organization is responsible for its Authorized Users and for all activity under its Organization Accounts.
Certain provisions of these Terms may apply differently depending on whether you use the Service as an Individual User, Consumer User, Authorized User, or Organization.
Nothing in these Terms limits any non-waivable rights you may have under applicable consumer, privacy, data protection, or other mandatory laws.
An Organization may designate administrators to manage user access, workspace settings, permissions, billing, Koins, Customer Content, usage history, and other account-level controls.
Authorized Users must comply with these Terms. Any breach of these Terms by an Authorized User may be treated as a breach by the applicable Organization.
An Organization is responsible for maintaining appropriate access controls, removing users who no longer require access, and ensuring that only authorized personnel access the Service.
If you are an Authorized User, your Organization may be able to access, manage, delete, export, restrict, or otherwise control your use of the Organization Account and Customer Content associated with that Organization Account.
You agree to use the Service only in compliance with applicable laws, regulations, contractual obligations, and these Terms.
You must not:
You retain ownership of your Customer Content.
You grant SE.ai a limited, worldwide, non-exclusive, royalty-free license to host, store, copy, transmit, process, analyze, display, and otherwise use Customer Content as necessary to provide, secure, maintain, support, troubleshoot, and improve the Service; comply with law; enforce these Terms; prevent abuse; and as otherwise described in our Privacy Policy or any applicable written agreement.
You represent and warrant that you have all rights, permissions, consents, and authority necessary to provide Customer Content to SE.ai and to permit SE.ai to process it as described in these Terms.
You are solely responsible for the accuracy, legality, reliability, and appropriateness of your Customer Content.
The Service is not designed for, and must not be used to create, receive, maintain, transmit, or process, protected health information ("PHI") or electronic protected health information ("ePHI") as those terms are used under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations ("HIPAA").
SE.ai is not intended to be used as a HIPAA-compliant service. SEAI Solutions, Inc. does not act as a Business Associate under HIPAA through the standard Service.
You must not upload, submit, enter, transmit, or otherwise provide PHI, ePHI, patient-identifiable information, medical records, DICOM files containing patient identifiers, clinical records containing identifiable patient information, or other regulated health information to the Service. This restriction applies to all prompts, queries, chats, device descriptions, forms, notes, messages, documents, and other inputs submitted to the Service.
You are solely responsible for reviewing, redacting, and de-identifying all information before providing it to the Service.
If SE.ai determines or reasonably suspects that information submitted to the Service contains PHI, ePHI, patient-identifiable information, or other prohibited regulated health information, SE.ai may suspend processing, restrict access, delete the information, require you to remove or replace the information, suspend the affected account or workspace, and take other steps reasonably necessary to protect the Service and comply with applicable law.
You agree to indemnify and hold harmless SE.ai from and against any claims, losses, liabilities, penalties, costs, and expenses arising from your unauthorized submission of PHI, ePHI, patient-identifiable information, or other prohibited regulated health information.
The Service may use artificial intelligence, machine learning, retrieval systems, search indexes, embeddings, structured reasoning workflows, and third-party AI service providers to generate analyses, summaries, comparisons, recommendations, drafts, reports, and other outputs.
You are responsible for reviewing and validating all outputs before relying on them. Outputs may be incomplete, inaccurate, outdated, non-exhaustive, or unsuitable for your specific regulatory, legal, clinical, technical, or business context.
SE.ai does not use Customer Content to train third-party foundation models. SE.ai does not use Customer Content to train SE.ai foundation models or proprietary regulatory models unless you expressly authorize such use or enter into a separate written agreement with SE.ai.
To provide the Service, SE.ai may create account-specific or workspace-specific indexes, embeddings, metadata, summaries, intermediate files, logs, or derived artifacts. These are used to provide, secure, maintain, support, and troubleshoot the Service and are not used to train foundation models unless expressly authorized or otherwise agreed in writing.
Where SE.ai uses third-party AI service providers to provide inference or related processing, SE.ai requires such providers to process Customer Content only to provide services to SE.ai and not to use Customer Content to train their foundation models.
Third-party AI service providers may retain Customer Content or related processing data for abuse monitoring, security, debugging, reliability, or legal compliance purposes for no longer than thirty (30) days, unless a shorter period is agreed in writing or longer retention is required by law.
SE.ai may use aggregated, de-identified, or telemetry data to monitor performance, detect abuse, improve reliability, develop features, and improve the Service, provided that such data does not identify you or disclose your Customer Content.
Your use of the Service is subject to SE.ai's Privacy Policy, which explains how SE.ai collects, uses, discloses, retains, and protects Personal Information.
If an Organization requires a Data Processing Addendum, Security Addendum, enterprise agreement, or other data protection agreement, such agreement must be executed separately and will control in the event of a conflict with these Terms, to the extent of that conflict.
Nothing in these Terms limits any privacy or data protection rights you may have under applicable law.
"Confidential Information" means non-public information disclosed by one party to the other that is identified as confidential or should reasonably be understood to be confidential based on the nature of the information and circumstances of disclosure, including non-public business, technical, regulatory, product, security, financial, and strategic information.
SE.ai will treat Customer Content as your Confidential Information, subject to these Terms, the Privacy Policy, and any applicable written agreement.
Each party agrees to use the other party's Confidential Information only as permitted under these Terms or an applicable written agreement and to protect it using reasonable care.
Confidential Information does not include information that is publicly available, already known without restriction, independently developed without use of the other party's Confidential Information, or rightfully received from a third party without confidentiality obligations.
A party may disclose Confidential Information where required by law, subpoena, court order, regulatory request, or other legal process, provided that, where legally permitted, it gives reasonable notice to the other party and cooperates in efforts to limit disclosure.
SE.ai may offer paid features, usage-based workflows, platform credits, or other paid services. Koins may be used to access eligible Service features, workflows, reports, analyses, or other paid functions.
Prices, Koin requirements, included features, and applicable taxes will be disclosed at or before purchase where applicable.
Purchased Koins do not expire. Free, promotional, bonus, incentive-based, or platform-granted Koins expire one year after the date they are granted, unless SE.ai states a different expiration period at the time of grant.
Koins are non-refundable, non-transferable, not redeemable for cash, and may be used only within the Service.
All Koin purchases are final and non-refundable except where required by applicable law or expressly stated at the time of purchase.
If you are a Consumer User in a jurisdiction that provides mandatory cancellation, withdrawal, refund, or other consumer rights, nothing in these Terms limits those non-waivable rights.
SE.ai may change pricing, Koin requirements, available features, or promotional Koin rules prospectively. Any material pricing changes will not apply retroactively to purchases already completed, except as permitted by applicable law or expressly agreed.
SE.ai does not currently offer automatically renewing subscriptions. If SE.ai offers subscriptions or automatically renewing plans in the future, the applicable renewal, billing, cancellation, and trial terms will be disclosed before enrollment.
SE.ai may use third-party payment processors. Payment processing may be subject to the payment processor's own terms and privacy policy.
SE.ai Technology is owned by SE.ai or its licensors.
Subject to your compliance with these Terms, SE.ai grants you a limited, non-exclusive, non-transferable, non-sublicensable, revocable right to access and use the Service for your internal business or individual regulatory workflow purposes, as applicable.
Except as expressly permitted by these Terms, you may not copy, modify, distribute, sell, lease, sublicense, publicly display, publicly perform, create derivative works of, or otherwise exploit SE.ai Technology without SE.ai's prior written permission.
No rights are granted except as expressly stated in these Terms.
If you provide comments, suggestions, ideas, requests, or feedback regarding the Service ("Feedback"), you grant SE.ai a perpetual, irrevocable, worldwide, royalty-free right to use such Feedback without restriction or compensation, provided that SE.ai does not disclose your Confidential Information in doing so.
The Service may integrate with, link to, or rely on third-party services, data sources, websites, APIs, AI service providers, cloud providers, payment processors, analytics tools, or other third-party technologies.
SE.ai is not responsible for third-party services or content, and your use of third-party services may be governed by separate terms and privacy policies.
Regulatory databases, FDA materials, public records, guidance documents, standards information, and third-party materials may be incomplete, outdated, modified, unavailable, or subject to third-party rights. You are responsible for verifying all third-party information before relying on it.
The Service provides AI-assisted workflow support and informational tools only. The Service does not provide legal, regulatory, medical, clinical, engineering, quality-system, or other professional advice.
Use of the Service does not create an attorney-client, consultant-client, physician-patient, fiduciary, or other professional relationship between you and SE.ai.
SE.ai does not guarantee FDA clearance, approval, authorization, acceptance, substantial equivalence, classification, product code assignment, Q-Submission feedback, submission success, regulatory strategy acceptance, or any other regulatory, legal, clinical, technical, or business outcome.
You remain solely responsible for all decisions, submissions, representations, claims, documentation, testing strategies, regulatory positions, and communications with FDA or any other regulator, notified body, customer, investor, partner, or third party.
You should consult qualified regulatory, legal, clinical, medical, engineering, quality-system, and other professionals before relying on Service outputs.
You must independently review, verify, and validate all outputs, citations, references, predicate device matches, product code suggestions, classification analyses, substantial equivalence assessments, testing recommendations, draft documents, and other Service-generated materials.
You must not submit any Service-generated content to FDA or any other governmental or regulatory body without appropriate expert review, verification, and approval.
SE.ai is not responsible for errors, omissions, outdated information, unsupported assumptions, hallucinations, misclassifications, or other inaccuracies in outputs, except to the extent liability cannot be excluded under applicable law.
SE.ai may modify, suspend, discontinue, limit, or replace any part of the Service at any time.
SE.ai does not guarantee that the Service will be uninterrupted, secure, error-free, or available at all times.
Some features may be labeled or treated as alpha, beta, preview, experimental, or evaluation features. Such features may be incomplete, unstable, subject to change, or discontinued without notice and should not be used as the sole basis for high-stakes decisions.
You must not, without SE.ai's prior written authorization, probe, scan, test, attack, bypass, disable, circumvent, compromise, or attempt to compromise the security, integrity, availability, confidentiality, or performance of the Service or related systems, networks, applications, data, models, or infrastructure.
Unauthorized security testing, vulnerability scanning, denial-of-service activity, credential attacks, scraping, data exfiltration, prompt injection attacks, model extraction, malicious automation, or attempts to access non-public systems or data are strictly prohibited.
If SE.ai reasonably suspects a security violation, abuse, fraud, unauthorized access, or material breach of these Terms, SE.ai may suspend or terminate access, restrict features, preserve relevant records, notify affected parties or authorities where appropriate, and take other steps reasonably necessary to protect the Service, SE.ai, users, and third parties.
SE.ai may retain records reasonably necessary to investigate, prevent, or respond to security incidents, abuse, fraud, legal claims, regulatory inquiries, law enforcement requests, or violations of these Terms. Such retention will be limited to information reasonably relevant to the matter and maintained only for as long as reasonably necessary for those purposes, subject to applicable law and SE.ai's data retention policies.
You may stop using the Service at any time. You may request account deletion according to SE.ai's account deletion process.
SE.ai may suspend or terminate your access to the Service if you violate these Terms, fail to pay applicable fees, create legal or security risk, misuse the Service, submit prohibited content, or if SE.ai reasonably believes suspension or termination is necessary to protect the Service, users, SE.ai, or third parties.
Upon termination, your right to access and use the Service will cease.
Sections that by their nature should survive termination will survive, including provisions regarding Customer Content, AI outputs, PHI/ePHI restrictions, confidentiality, intellectual property, fees, disclaimers, limitations of liability, indemnification, dispute resolution, and miscellaneous terms.
Following account closure or deletion, SE.ai will delete or anonymize Customer Content and Personal Information according to the Privacy Policy, applicable data retention schedules, legal obligations, backup cycles, and any applicable written agreement.
Deletion may not be immediate from backups, logs, archives, or systems where retention is reasonably necessary for security, legal compliance, fraud prevention, dispute resolution, or enforcement of these Terms.
SE.ai will not retain Customer Content longer than reasonably necessary for the purposes described in these Terms, the Privacy Policy, or applicable written agreement, except as required or permitted by applicable law.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICE AND ALL OUTPUTS ARE PROVIDED "AS IS" AND "AS AVAILABLE," WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE.
SE.AI DISCLAIMS ALL WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, COMPLETENESS, RELIABILITY, AVAILABILITY, SECURITY, AND REGULATORY SUITABILITY.
SE.AI DOES NOT WARRANT THAT THE SERVICE OR OUTPUTS WILL BE UNINTERRUPTED, ERROR-FREE, SECURE, ACCURATE, COMPLETE, CURRENT, NON-INFRINGING, OR SUITABLE FOR ANY PARTICULAR REGULATORY, LEGAL, CLINICAL, TECHNICAL, OR BUSINESS PURPOSE.
NOTHING IN THESE TERMS EXCLUDES OR LIMITS WARRANTIES, GUARANTEES, OR RIGHTS THAT CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, SE.AI WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, ENHANCED, OR PUNITIVE DAMAGES; LOST PROFITS; LOST REVENUE; LOSS OF GOODWILL; LOSS OF DATA; BUSINESS INTERRUPTION; REGULATORY DELAY; FAILED SUBMISSION; OR COST OF SUBSTITUTE SERVICES, WHETHER ARISING IN CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE, OR OTHERWISE, EVEN IF SE.AI HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, SE.AI'S TOTAL LIABILITY FOR ALL CLAIMS ARISING OUT OF OR RELATING TO THE SERVICE OR THESE TERMS WILL NOT EXCEED THE GREATER OF: (A) THE AMOUNTS YOU PAID TO SE.AI FOR THE SERVICE DURING THE SIX MONTHS BEFORE THE EVENT GIVING RISE TO LIABILITY; OR (B) USD $100.
THE LIMITATIONS IN THIS SECTION APPLY TO THE MAXIMUM EXTENT PERMITTED BY LAW AND DO NOT LIMIT LIABILITY THAT CANNOT BE LIMITED UNDER APPLICABLE LAW.
FOR CONSUMER USERS, NOTHING IN THESE TERMS LIMITS ANY NON-WAIVABLE CONSUMER RIGHTS OR REMEDIES AVAILABLE UNDER APPLICABLE LAW.
You agree to defend, indemnify, and hold harmless SE.ai and its affiliates, officers, directors, employees, contractors, licensors, service providers, and agents from and against any claims, damages, losses, liabilities, penalties, fines, costs, and expenses, including reasonable attorneys' fees, arising out of or relating to:
SE.ai reserves the right to assume the exclusive defense and control of any matter subject to indemnification, and you agree to cooperate with SE.ai's defense.
This Section applies to Consumer Users only to the extent permitted by applicable law.
You must comply with all applicable export control, sanctions, and trade compliance laws.
You represent that you are not located in, organized under the laws of, or ordinarily resident in any country or region subject to comprehensive sanctions, and that you are not listed on any restricted-party list.
You must not use the Service for any purpose prohibited by export control, sanctions, or trade compliance laws.
If you believe that content available through the Service infringes your copyright or other intellectual property rights, please contact SE.ai at [email protected] with sufficient information to identify the allegedly infringing content and your rights.
SE.ai may remove or restrict access to allegedly infringing content and may terminate repeat infringers where appropriate.
SE.ai may update these Terms from time to time.
If SE.ai makes material changes, SE.ai will provide reasonable notice, such as by posting the updated Terms, sending an email, providing in-product notice, or requiring renewed acceptance.
Changes will be effective as stated in the updated Terms. Your continued use of the Service after the effective date of updated Terms constitutes acceptance of the updated Terms.
SE.ai will not materially expand its use of previously collected Customer Content for AI model training or unrelated purposes without appropriate notice and, where required by law or contract, your consent.
Nothing in this Section limits any non-waivable notice or consent rights available to Consumer Users under applicable law.
These Terms are governed by the laws of the State of Delaware, without regard to conflict of law principles.
Subject to any mandatory rights you may have under applicable law, the state and federal courts located in Delaware will have exclusive jurisdiction over disputes arising out of or relating to these Terms or the Service, and each party consents to personal jurisdiction and venue in those courts.
Nothing in this Section prevents SE.ai from seeking injunctive or equitable relief in any court of competent jurisdiction to protect its intellectual property, Confidential Information, systems, security, users, or the Service.
For Consumer Users, nothing in this Section limits any non-waivable rights to bring claims in, or receive the protection of, courts or laws required by applicable consumer protection law.
These Terms, together with the Privacy Policy and any applicable order form, enterprise agreement, Data Processing Addendum, security addendum, or other written agreement, constitute the entire agreement between you and SE.ai regarding the Service.
If any provision of these Terms is held invalid or unenforceable, the remaining provisions will remain in full force and effect.
You may not assign these Terms without SE.ai's prior written consent. SE.ai may assign these Terms in connection with a merger, acquisition, corporate reorganization, sale of assets, financing, or by operation of law.
SE.ai's failure to enforce any provision of these Terms is not a waiver of that provision.
Headings are for convenience only and do not affect interpretation.
If you have questions about these Terms, please contact us at:
SEAI Solutions, Inc.
A Delaware corporation doing business as SE.ai
Principal place of business: South Carolina
Email: [email protected]
Website: https://seai.chat
By creating an account, purchasing Koins, accessing SE.ai Workbench, or using the Service, you acknowledge that you have read, understood, and agree to be bound by these Terms.