Terms of Use

These Terms govern your use of the rmForge service ("Service") operated by M. L. Reo Consulting LLC, doing business as rmForge ("rmForge," "we," "us"). By creating an account or using the Service you agree to these Terms. The Service is in closed beta; access is by invitation only.

1. Beta Status and Service Changes

rmForge is provided free of charge during the closed beta. We may modify, suspend, withdraw, or terminate any part of the Service at any time, including individual user accounts, without notice and without liability. Features, pricing, rate limits, and storage retention may change.

2. Not Medical, Legal, or Regulatory Advice

rmForge outputs (including the Hazard Analysis Output Workbook, Hazard Questionnaire, and any other deliverable) are AI-generated drafts. They are not:

• Medical advice or device safety determinations.
• Regulatory submissions, certifications, or substitutes for FDA, EU MDR, or other regulatory filings.
• Legal advice on liability, warranty, or product compliance.
• A substitute for clinical evaluation by qualified medical professionals.
• A substitute for risk management performed by qualified engineers under ISO 14971:2019.

You acknowledge that every output requires qualified human review by a person competent in medical device risk management before any decision, regulatory submission, or product release.

3. Your Obligations

You agree that you will:

• Provide accurate information about your device, including its FDA class, intended use, and applicable standards.
• Not use the Service for a device whose risk class or regulatory pathway you have misrepresented.
• Not rely on rmForge outputs as the sole basis for risk-acceptance, regulatory submission, or product release decisions.
• Maintain qualified human review of every output before any use beyond engineering draft.
• Comply with all applicable laws including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and any regulations applicable to your jurisdiction and device class.
• Not upload third-party confidential information without authorization.
• Not attempt to reverse-engineer, scrape, automate, or abuse the Service.

4. Acceptable Use

You may not use the Service to develop, market, or evaluate devices intended for unlawful purposes, or for any device class or use that is materially misrepresented in your account or wizard responses. We may terminate access for misrepresentation at any time, without refund.

5. AI and Confidence

rmForge uses large language models from leading providers. AI outputs can contain factual errors, omissions, and hallucinations. We make no warranty that any output is accurate, complete, fit for any purpose, or compliant with any standard. Every output carries an internal confidence value that you should review before relying on the row.

6. Your Data

Uploaded documents (IFU, Product Requirements, etc.) and generated outputs remain your property. We process them only to deliver the Service. Customer data may be deleted at our discretion during beta. See the Privacy Policy for details on data handling, retention, and AI training (we do not train on your data).

7. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, the Service is provided "AS IS" and "AS AVAILABLE" without any warranty, express or implied, including warranties of merchantability, fitness for a particular purpose, accuracy, or non-infringement. M. L. Reo Consulting LLC and rmForge shall not be liable for any direct, indirect, incidental, consequential, or punitive damages arising from your use of the Service, including but not limited to: regulatory enforcement, product recall, patient harm, lost revenue, lost time, or any decisions made in reliance on rmForge outputs. Our aggregate liability to you for any claim is limited to USD $100.

8. Indemnification

You will indemnify and hold harmless M. L. Reo Consulting LLC, its members, employees, and contractors against any claim arising from (a) your use of rmForge outputs, (b) your medical device or its placement on the market, (c) your misrepresentation of device class or intended use, or (d) your violation of these Terms.

9. Governing Law and Disputes

These Terms are governed by the laws of the Commonwealth of Massachusetts, United States, without regard to its conflict-of-laws principles. Any dispute will be resolved by binding arbitration in Massachusetts under American Arbitration Association rules. You waive any right to participate in a class action.

10. Changes to These Terms

We may modify these Terms at any time. Continued use of the Service after any change constitutes acceptance. The "Effective" date at the top reflects the current version.

11. Contact

Questions or notice of dispute: support@rmforge.io.

These Terms reflect the closed-beta phase of rmForge. They will be replaced by a Termly-generated production Terms of Service at general availability. The Limitation of Liability and Indemnification provisions are intended to remain materially the same.