Getting started with a medical device Hazard Analysis

rmForge generates review-ready medical-device Risk Analysis documentation: Hazard Analysis (HA) or Failure Mode and Effects Analysis (FMEA). You sign up and book a working session with rmForge; we build your first analysis with you on a screen share and deliver a Hazard Analysis workbook plus a customer acknowledgment form to support your design history file.

Hazard Analysis consumes engineer hours, drifts between projects and review sessions, and is one of the artifacts FDA and Notified Body reviewers most often return for inconsistency, missing rows, or weak traceability. It is a project pain-point. rmForge is for medical-device manufacturers, contract design houses, and consultants across all device classes who want a structured Risk Analysis: a Hazard Analysis built against a controlled and consistent ruleset, with traceability to Product Requirements, then, if needed, a Design FMEA or Process FMEA built from it.

Sign up at /signup and confirm your email, then book your onboarding meeting at /book. On a screen share, we build your first Hazard Analysis with you. You decide on services and payment at the session. After payment, the review-ready workbook is emailed to you and is available in your dashboard. Once the Hazard Analysis is finished, the rmForge operator can start a Design FMEA or Process FMEA from it with you.

Bring what you have to the session. We can start from the device questionnaire alone for a preliminary Hazard Analysis. For a richer analysis, have your Instructions for Use (IFU) PDF, Product Requirements, User Needs and Intended Use, and any existing Hazard List ready. The richer the inputs, the more specific the HA rows we generate. A Design FMEA also reads your bill of materials and requirements matrix if you bring them for the Hazard Analysis, and its part numbers come only from your bill of materials. A Process FMEA reads the process flow, router or control plan you bring when it is started.

A typical Hazard Analysis for a single Class II device completes in 10 to 15 minutes from upload to download. You can close the browser and we'll email you when it's ready. Medical Electrical equipment and multiple subsystems can take an hour or more depending on the number of subsystems uploaded through documentation or the wizard.

No. The home page offers a sample Hazard Analysis for your review.

No. rmForge runs entirely in the browser on rmforge.io. There's nothing to install and nothing to configure beyond a verified email address.

Each team member signs up with their own email. Team-shared analysis workspaces are on the roadmap.

Current versions of Chrome, Safari, Edge, and Firefox. We do not test against Internet Explorer.

Signing up, booking, and the working session itself need no payment. At the end of the session you decide on services and payment; deliverables, including the Hazard Analysis workbook and any Design FMEA or Process FMEA workbook, are provided after payment. Ongoing support is a flat-fee subscription quoted in a proposal after your first meeting.