SE.ai is an AI-native regulatory intelligence platform built to support medical device companies, regulatory professionals, consultants, and innovators throughout the FDA 510(k) workflow.

SE.ai helps users with regulatory research, pathway planning, predicate device analysis, substantial equivalence assessment, Q-Submission preparation support, and 510(k) document drafting support.

SE.ai's core capabilities include:

SE.ai is designed to help transform regulatory uncertainty into structured, reviewable regulatory intelligence. SE.ai does not replace qualified regulatory, legal, clinical, medical, engineering, or quality-system professionals.

SE.ai is designed for users across the medical device and regulatory ecosystem, including:

SE.ai supports both Individual Users and Organization users. Organization accounts may include administrators who manage access, usage, Koins, workspace activity, and account-level settings.

General-purpose AI tools are built for broad information tasks. SE.ai is purpose-built around FDA medical device regulatory workflows, especially the 510(k) framework.

Rather than operating as a generic chatbot, SE.ai combines regulatory workflow structure, specialized AI agents, curated regulatory sources, and human-review checkpoints to support more organized and reviewable regulatory analysis.

Key differentiators include:

SE.ai acts as an intelligent regulatory workflow assistant. It helps users identify issues earlier, organize evidence more consistently, and prepare materials more efficiently, but users remain responsible for final judgment and regulatory decisions.

No. SE.ai does not use Customer Content to train third-party foundation models.

SE.ai also 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.

Customer Content includes prompts, queries, device descriptions, regulatory information, messages, notes, workflow inputs, and outputs generated specifically for you based on your inputs.

Our approach is not only a privacy commitment; it is also part of how SE.ai is designed to produce defensible regulatory intelligence. SE.ai's regulatory intelligence is supported by a proprietary training and inference framework internally called CoE (Chain-of-Evidence). CoE is an evidence-based LLM training and inference methodology focused on device technological characteristics decoupling, evidence anchoring, and structured regulatory reasoning.

To keep outputs aligned with FDA logic and precedent-based regulatory analysis, SE.ai's model development and regulatory knowledge systems rely on curated regulatory sources, including FDA-cleared device information, official FDA guidance documents, recognized standards information, public regulatory records, and established medical device literature.

Customer inputs often describe uncleared devices, hypothetical concepts, draft product designs, early-stage engineering assumptions, or unvalidated regulatory strategies. These materials are confidential to the customer and are not appropriate training material for a precedent-oriented regulatory intelligence system. Mixing unverified customer product concepts into a training corpus could reduce the reliability, traceability, and regulatory defensibility of future outputs.

For that reason, Customer Content is kept separate from model-training pipelines. Your inputs are processed to provide the Service to you, such as generating analyses, comparisons, summaries, reports, and regulatory workflow outputs. SE.ai may create account-specific or workspace-specific indexes, embeddings, metadata, summaries, logs, or intermediate artifacts to provide, secure, maintain, troubleshoot, and support the Service. These artifacts are not used to train foundation models unless expressly authorized or otherwise agreed in writing.

Where SE.ai uses third-party AI service providers, we require those 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 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.

Your proprietary information remains yours and is processed only for the purposes described in our Terms of Use, Privacy Policy, and any applicable written agreement.

Data security is a core principle of SE.ai. We use reasonable administrative, technical, and organizational safeguards designed to protect information against unauthorized access, loss, misuse, alteration, and disclosure.

These safeguards may include encryption in transit, encryption at rest where appropriate, access controls, authentication controls, password protection, logging, monitoring, vulnerability management, backup controls, personnel access restrictions, and vendor controls.

No online service can guarantee absolute security. Users are responsible for maintaining strong passwords, protecting account credentials, limiting access to authorized personnel, and promptly notifying SE.ai if they suspect unauthorized account access.

For security concerns, contact us at [email protected].

No. SE.ai standard accounts are not designed for protected health information ("PHI") or electronic protected health information ("ePHI") under HIPAA.

Do not enter, upload, submit, or transmit patient-identifiable information, medical records, DICOM files containing patient identifiers, clinical records containing identifiable patient information, or other regulated health information into SE.ai.

This restriction applies to prompts, queries, chats, device descriptions, forms, notes, messages, documents, and all other inputs.

SE.ai is intended for regulatory workflow support using device descriptions, FDA materials, public regulatory information, and non-PHI customer inputs. If you have clinical or patient-related materials, you must remove patient identifiers and use only de-identified or redacted information before entering it into SE.ai.

SEAI Solutions, Inc. does not act as a HIPAA Business Associate through the standard Service.

Yes. SE.ai may use Google Analytics and similar analytics tools to understand website traffic, usage patterns, performance, and Service interactions.

We use a consent banner or similar consent mechanism for non-essential cookies and similar technologies where required by applicable law. You may manage cookie preferences through the consent banner where available or through your browser settings.

SE.ai does not sell Personal Information. SE.ai does not currently share Personal Information for cross-context behavioral advertising as those terms are used under California privacy law.

If SE.ai enables advertising features, remarketing, Google signals, ads personalization, or similar advertising-related features in the future, we will update our Privacy Policy and provide any notices, consent mechanisms, or opt-out choices required by applicable law.

SE.ai uses a credit-based pricing model built around Koins, our platform credits.

Koins may be used to access eligible workflows, reports, analyses, and paid features within the Service.

Key pricing points:

Our goal is to let users engage with regulatory workflow support incrementally, rather than requiring large upfront commitments before value is demonstrated.

No. SE.ai is designed to augment and empower human expertise, not replace it.

Successful FDA submissions require expert judgment across regulatory strategy, device design, clinical context, testing evidence, risk analysis, quality systems, and FDA reviewer expectations. SE.ai helps automate and organize time-consuming research and drafting tasks, but final decisions remain the responsibility of qualified professionals.

SE.ai can support tasks such as:

All SE.ai outputs should be independently reviewed, verified, and validated before being used for regulatory, legal, clinical, technical, or business decisions.

SE.ai does not provide legal, regulatory, medical, clinical, engineering, or quality-system advice. SE.ai does not guarantee FDA clearance, approval, authorization, acceptance, substantial equivalence, product code assignment, Q-Submission feedback, submission success, or any specific regulatory outcome.

SE.ai-generated content should not be submitted directly to FDA or any other regulatory body without appropriate expert review, verification, and approval.

SE.ai outputs may include summaries, draft language, comparison tables, risk matrices, regulatory reasoning, or suggested evidence structures. These outputs may be incomplete, inaccurate, outdated, non-exhaustive, or unsuitable for your specific device or regulatory context.

Users are responsible for independently verifying all citations, product code suggestions, predicate matches, substantial equivalence analyses, testing recommendations, draft documents, and regulatory positions before relying on them.

Yes. SE.ai supports both Individual Users and Organization users.

Individual Users are responsible for their own use of the Service, Customer Content, purchases, and compliance with SE.ai's Terms of Use.

Organizations may create Organization Accounts and designate administrators. Organization administrators may manage users, permissions, workspace activity, Koins, Customer Content, usage history, and account-level settings.

If you use SE.ai through an Organization Account, your Organization may be able to access, manage, export, delete, restrict, or otherwise control information associated with that Organization Account.

SE.ai may make a Data Processing Addendum ("DPA") available for Organization customers where appropriate.

The DPA is intended for Organization customers and applies only when incorporated into an applicable agreement between SEAI Solutions, Inc. and the Organization, or otherwise accepted by both parties.

The DPA does not apply to standard individual use of the Service unless expressly agreed in writing.

For DPA-related questions, contact [email protected].

SE.ai is operated by SEAI Solutions, Inc., a Delaware corporation doing business as SE.ai, with its principal place of business in South Carolina.

For legal, privacy, security, or account questions, contact us at [email protected].

Website: https://seai.chat