The rmForge Platform

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  • What language model does rmForge use?

    rmForge uses state-of-the-art commercial large language models from leading providers, with a failover chain so that an outage at any one provider does not interrupt your analysis. Specific model selection is managed by the platform and tuned for the risk-analysis task.

  • How long does rmForge keep my files?

    Uploaded source documents and generated outputs are retained according to your choice as account initiation. They can be deleted immediately or they are retained for the life of your account. You can request deletion at any time by emailing support@rmforge.io but it will require an authentication from you.

  • Can I download my data?

    Yes. Every completed analysis produces a downloadable Hazard Analysis workbook plus a signed customer acknowledgment. Both download from your dashboard. There is no lock-in.

  • Does rmForge train its models on my data?

    No. Customer data is never used for model training. Our AI model providers contractually exclude customer data from training under their API terms. rmForge's invocation pattern is API-only. No model traffic touches the chat product. Provider API terms contractually exclude API traffic from training.

  • How is rmForge different from a generic LLM?

    Three things: (a) hard-coded task-specific sections and a controlled prompt designed around ISO 14971 and our internal specifications; (b) literature based risk techniques, purpose built code, deterministic grammar, and logic rules plus risk math (Po and Risk Level via table lookup, not AI judgment); (c) validation rules that check every row against the specification and flag any row that cannot be validated.

  • What if the LLM produces a row that doesn't match the spec?

    rmForge runs an extensive validation rule set on every row. Rows that fail validation are automatically rechecked, and any row that cannot be resolved is clearly flagged in the output for human review just like a normal risk analysis process, but with significant time savings.

  • How does rmForge handle hallucinations?

    Risk math is deterministic, not AI-generated. Po and Risk Level are looked up from controlled tables. Source quotations are verified against the uploaded document text. Sequence of Events, Hazardous Situation, and Harms follow programmed rules and logic significantly narrowing LLM decision making to a finite rule set in the similar manner that a qualified human would evaluate risk.

  • Can I customize the HA prompt?

    No. The prompt is controlled under our internal change-management process. Customization can be contracted through support@rmforge.io.

  • Does rmForge support FMEA?

    Not at this time. FMEA modules (Use FMEA, Design FMEA, Process FMEA) are planned for a later phase.

  • Can rmForge handle non-English IFUs?

    Today, English only.

  • Is rmForge a medical device?

    No. rmForge is not a medical device and not Software as a Medical Device (SaMD). It is a *user review-required* documentation-generation tool. The user remains the legal manufacturer with all responsibility for risk decisions.

  • Who is responsible for the final risk analysis?

    You are. rmForge provides a structured first draft, but the manufacturer is responsible for the analysis under ISO 14971, ISO 13485, and FDA QMSR. The customer acknowledgment form captures this.

  • How often does rmForge update its rules?

    Major rule changes (severity scale, probability scale, validation rules) are controlled under an internal change-management process with revision history. Cosmetic updates ship continuously. Each completed analysis records the rule-set version in effect at the time.

  • Where is rmForge's infrastructure hosted?

    Hosted on industry-standard cloud infrastructure. The application, database, and storage run on tier-1 US-region cloud providers. All traffic is HTTPS end-to-end.