Throughout these Terms the following words have the meanings set out below:
You must be at least 18 years old and have the legal authority to enter into a binding agreement to use the Service. If you are accepting these Terms on behalf of a company or other legal entity, you represent that you have the authority to bind that entity.
You agree to provide accurate, current, and complete information during registration, and to keep your account credentials secure. You are responsible for all activity that occurs under your account. You must notify us immediately at support@clemtechmedical.com if you suspect unauthorized access to your account.
We reserve the right to refuse registration to anyone for any reason at our discretion.
RAi is a software-as-a-service (SaaS) platform designed to help medical device and life sciences companies manage regulatory affairs documentation, conduct quality management system (QMS) activities, and access AI-assisted guidance on topics such as FDA 510(k) submissions, ISO 13485 compliance, and 21 CFR Part 820.
Features include document management and e-signature (21 CFR Part 11-aligned), project and task tracking, AI chat assistance, FDA predicate device search, audit preparation tools, team collaboration, and document template generation.
We reserve the right to modify, add, or remove features of the Service at any time. We will make reasonable efforts to notify you of material changes.
We may offer a free trial period (currently 14 days) during which you can access certain features of the Service at no charge. At the end of the trial period, continued access requires a paid subscription. We reserve the right to modify or discontinue the free trial at any time.
Paid subscription plans are billed in advance on a monthly or annual basis as selected at the time of purchase. Plan details, including pricing and feature limits, are described on our website and may be updated from time to time. Your continued use of the Service after a price change constitutes acceptance of the new pricing.
Subscriptions automatically renew at the end of each billing period unless you cancel before the renewal date. You can cancel your subscription at any time through your account settings or by contacting us.
All subscription fees are non-refundable except as required by law. If you cancel mid-period, you will retain access until the end of the current billing period but will not receive a prorated refund. Exceptions may be made at our sole discretion for billing errors or extraordinary circumstances.
You agree to use the Service only for lawful purposes and in accordance with these Terms. You must not use the Service to:
We reserve the right to suspend or terminate accounts that violate these policies.
The Service, including all software, algorithms, interfaces, content, templates, and documentation, is owned by Clemtech or its licensors and is protected by copyright, trademark, and other intellectual property laws. These Terms do not grant you any right, title, or interest in the Service beyond the limited license described herein.
Subject to your compliance with these Terms and payment of applicable fees, we grant you a limited, non-exclusive, non-transferable, revocable license to access and use the Service for your internal business purposes during the subscription term.
If you provide us with feedback, suggestions, or ideas about the Service, you grant us a perpetual, irrevocable, royalty-free, worldwide license to use such feedback for any purpose without compensation to you.
Document templates and AI Output generated by the Service may be used, modified, and distributed by you for your internal business purposes, subject to the restrictions in Section 8.
You retain ownership of all Customer Data you upload to or create within the Service. We do not claim any ownership interest in your Customer Data.
By using the Service, you grant us a limited, non-exclusive license to store, process, display, and transmit your Customer Data solely to the extent necessary to provide and improve the Service, respond to support requests, and comply with legal obligations.
We do not use your Customer Data to train our own AI models. Anthropic's API usage policy states that data sent via the API is not used for training by default.
You may export your data at any time through the Service. Upon cancellation, we retain your data for 90 days to allow retrieval, after which it may be permanently deleted. Audit logs may be retained for up to 7 years for regulatory compliance purposes.
You are solely responsible for the accuracy, quality, integrity, and legality of your Customer Data and for ensuring you have all rights necessary to upload it to the Service.
AI-generated content may contain errors, omissions, or outdated information. Regulatory requirements change frequently, and RAi does not guarantee that any AI Output reflects the most current guidance from the FDA, ISO, or other regulatory bodies.
You are solely responsible for reviewing, validating, and deciding whether to rely on any AI Output. Clemtech is not liable for any decisions you make based on AI-generated content.
AI Outputs must not be submitted to regulatory agencies as official documentation without independent expert review and appropriate validation by your regulatory team.
RAi is intended for use with QMS documentation, regulatory submissions, device technical files, and similar non-patient-specific content. If your use case requires processing PHI or you believe a BAA is necessary, please contact us at legal@clemtechmedical.com before uploading any such data.
You assume sole responsibility for ensuring that any data you upload complies with applicable laws and regulations, including HIPAA, GDPR, and other data protection frameworks.
Each party agrees to maintain the confidentiality of the other party's non-public business information and to use it only for the purposes of the business relationship under these Terms. This obligation does not apply to information that is publicly available, was already known, is lawfully obtained from a third party, or is independently developed.
We maintain administrative, technical, and physical security measures to protect your Customer Data. Please see our Security page for details.
Payment is processed by Stripe, Inc. You agree to provide current, complete, and accurate payment information. By providing payment information, you authorize us to charge your payment method for all fees incurred.
If payment fails, we will notify you and may suspend your access until payment is resolved. Accounts delinquent for more than 30 days may be terminated.
We may apply taxes (including VAT, GST, or sales tax) where required by law. All billing disputes must be reported within 60 days of the charge date by emailing billing@clemtechmedical.com.
You may cancel your subscription at any time through your account settings. Cancellation takes effect at the end of the current billing period.
We may suspend or terminate your access immediately, without prior notice or liability, if you materially breach these Terms, fail to pay fees, or if we are required to do so by law.
Upon termination, your right to access the Service ceases. We will retain your Customer Data for 90 days post-termination before deletion. Sections 6, 8, 13, 14, 15, and 16 survive termination.
THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMITTED BY LAW, CLEMTECH DISCLAIMS ALL WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT.
We do not warrant that the Service will be uninterrupted, error-free, or secure, or that AI Output will be accurate, complete, or reliable.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL CLEMTECH BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING LOSS OF PROFITS, LOSS OF DATA, BUSINESS INTERRUPTION, OR COST OF SUBSTITUTE GOODS OR SERVICES, ARISING OUT OF OR IN CONNECTION WITH THESE TERMS OR THE SERVICE.
OUR TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS SHALL NOT EXCEED THE GREATER OF (A) TOTAL FEES PAID BY YOU IN THE TWELVE MONTHS PRECEDING THE CLAIM, OR (B) ONE HUNDRED US DOLLARS ($100).
You agree to indemnify, defend, and hold harmless Clemtech and its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, costs, and expenses (including reasonable attorneys' fees) arising out of or in connection with your use of the Service, your Customer Data, your violation of these Terms, or your violation of any rights of a third party.
These Terms are governed by the laws of the State of Delaware, United States, without regard to conflict of law principles.
Before filing any formal legal action, you agree to contact us at legal@clemtechmedical.com and attempt to resolve the dispute informally within 60 days.
Any unresolved dispute shall be settled by binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules, in Delaware. The arbitrator's decision shall be final and binding.
YOU WAIVE YOUR RIGHT TO PARTICIPATE IN A CLASS ACTION LAWSUIT OR ARBITRATION. ALL DISPUTES MUST BE BROUGHT IN YOUR INDIVIDUAL CAPACITY.
We may modify these Terms from time to time with at least 14 days' notice of material changes by email or prominent notice within the Service. Your continued use after the effective date constitutes acceptance of the revised Terms.
If you have any questions about these Terms: