Regulatory documentation shouldn't be so tedious.

BaseRef is the easiest way for medical device startups to create requirements, risk, and test documentation with full traceability.

Satisfy IEC 62304, ISO 14971, and FDA Design Controls without manually tracing or fighting with legacy tools.

Early access is rolling out to a small group of startups. No spam.

A Software Requirements Specification open in BaseRef, beside the project's document tree

Features

The item graph: needs, risks, requirements and design outputs joined by trace wires
The risk register with pre- and post-mitigation scoring and linked controls
A Product Requirements Specification open in the BaseRef document editor 
$ curl https://api.baseref.com/v1/projects/pump-firmware/items/SRS-0042
{
  "id": "SRS-0042",
  "type": "Software Requirement",
  "title": "Suspend delivery on low glucose",
  "text": "The pump firmware shall suspend basal insulin delivery when the paired CGM reports glucose below 70 mg/dL for two consecutive readings.",
  "version": 7,
  "approved": true,
  "updated_at": "2026-09-18T14:02:11Z",
  "traces": {
    "upstream": [
      { "id": "NEED-0007", "type": "User Need", "title": "Protect the user from hypoglycemia" },
      { "id": "RSK-0012",  "type": "Risk", "control_option": "a", "title": "Insulin over-delivery during hypoglycemia" }
    ],
    "downstream": [
      { "id": "SWI-0019", "type": "Software Item", "title": "Delivery controller" },
      { "id": "TC-0088",  "type": "Test Case", "title": "Low-glucose suspend, bench" },
      …

About

I've spent 12 years developing embedded software for medical devices, and I've never been satisfied with the tools available for med device startups. BaseRef is the tool I've always wanted.
Jeff Gable
Jeff Gable Founder, BaseRef LinkedIn

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