The Hazard Analysis workbook you receive
← Return to FAQWhat file format is the Hazard Analysis output?
A Microsoft Excel workbook (.xlsx) with several sheets. In order: Cover Page, Hazard Analysis (32 columns), Risk Region, Scales, Column Descriptions, Hazard Questionnaire, and Disclaimer. For a system made of several parts, there is one Hazard Analysis sheet per part, plus an Integration sheet when needed. A revised workbook also has a Change Summary sheet after the Hazard Analysis sheets. The revision number is on the Cover Page. Results for medical electrical equipment are in column Q of the Hazard Analysis sheet, not on a separate sheet.
Can I edit the Excel output?
Yes. The workbook is not locked, so you can change any cell. If you change a probability or Severity value, the Po (probability that harm occurs) and Risk Level cells update on their own. rmForge does not read your edits back in. To start the next revision, tell the rmForge operator what changed in your design; the operator starts the revision with you. rmForge builds the new revision from its stored copy of the prior revision and your description. Edits you made in a downloaded workbook are not carried forward, so reapply any you want to keep.
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?
The Hazard Analysis sheets print on Tabloid paper (11 x 17 inches), turned sideways, one page wide. The Cover Page and the reference sheets print on Letter paper (8.5 x 11 inches).
Why is there a separate Hazard Questionnaire tab?
The Hazard Questionnaire tab lists the hazard identification questions rmForge answers for your device. They are adapted from the safety questions in ISO/TR 24971, the International Organization for Standardization (ISO) technical report that gives guidance on ISO 14971. Each row shows the question, whether it applies, the evidence, and the references. The tab is also a useful record for design review meetings.
What is the "Methodology" cell in the output?
The Cover Page has a Methodology Basis cell and a Methodology Statement. They name the reference standards, starting with ISO 14971:2019, the International Organization for Standardization (ISO) standard for medical device risk management. They also explain how risk is estimated: P1 and P2, the lookup tables for Po (the probability that harm occurs) and Risk Level, and the rule that sets P1 to 5 for software causes with Severity 4 or 5. The workbook does not record a rule set version.
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?
Partly. There is no separate Product Requirement or User Need column. Column S (RCM Requirements) lists each proposed Risk Control Measure (RCM) as a requirement. When the requirements you bring supply an ID, it is shown with the requirement text. Columns T and U list the design output and the verification for each RCM. They use your document IDs where rmForge can match them. Otherwise they show a generated ID or a placeholder for you to complete. User Need links are not shown in the workbook today.
Can I re-run an analysis after editing my IFU?
Yes. Tell the rmForge operator what changed in your Instructions for Use (IFU) or design. The operator describes the change to rmForge, which may ask one or two follow-up questions. It then regenerates the hazard rows, using the prior revision as context, and delivers the next revision as a new workbook. Changes are marked in the hazard rows, and a Change Summary tab lists each added, removed, and changed item with its previous and new values. The prior revision is kept unchanged. Revise works from your description. It does not read an edited IFU file. To have the edited IFU file itself analyzed, email support@rmforge.io and we will run it with you as a new analysis.
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.