Outputs and Deliverables
← Return to FAQWhat file format is the Hazard Analysis output?
A multi-sheet Microsoft Excel workbook (\*.xlsx). Sheets: Hazard Analysis (26 columns), Hazard Questionnaire (HQ), Essential Performance evaluation (for ME devices), Revision History.
Can I edit the Excel output?
Yes. The workbook is unprotected. Your edits are yours. rmForge does not re-import edits today; round-trip editing and phase updates are a roadmap feature.
What is the customer acknowledgment form?
A short, signed acknowledgment that you (the manufacturer) reviewed and accepted the rmForge-generated draft. It supports your design history file by recording manufacturer review and sign-off of a draft Hazard Analysis that required cross functional team review and approval.
What paper size does the Excel workbook print to?
Tabloid (11 x 17 inches).
Why is there a separate Hazard Questionnaire tab?
The HQ tab captures the high-level device-classification answers (intended use, patient population, environment, ME status, EP status) that drive the HA Agent's prompt construction. It's also a useful artifact for design-review meetings and is demonstrative of following a systematically-phased approach to design and risk management.
What is the "Methodology" cell in the output?
A short statement identifying the rule set used to generate the analysis. It records the rule-set version in effect at the time of the analysis and notes ISO 14971 as a reference standard.
What is the "Analyst" cell in the output?
A placeholder that the customer fills in. The platform is not credited as an analyst; the default reads "[Requires qualified reviewer]" until you sign off.
Can I get a PDF version?
You can print the .xlsx to PDF from Excel. A native PDF export is on the roadmap.
Does the output include traceability to my Product Requirements?
Yes. Every HA row includes a column for the linked Product Requirement (PR-###) and User Need (UN-###). When your uploaded requirements use explicit IDs, those are preserved. Otherwise rmForge auto-assigns PR-001, PR-002, etc. except for a preliminary hazard analysis that has no documentation.
Can I re-run an analysis after editing my IFU?
Yes. Upload the revised IFU as a new analysis. Differential re-analysis (only the rows affected by the change) is on the roadmap.
Do you provide consulting services?
Yes. Contact <proposals@rmforge.io> with a subject line of "Consulting Requested" and a qualification form will be sent to you. Consulting is provided on a project basis and not an hourly basis. Our risk management consultants are medtech veterans with over 20 years of direct device development and risk management experience as individuals. We also offer on-premises (on-prem) deployment, custom agentic workflows, AI agents, applications, and AI training.