Regulatory Submission Support

Draft regulatory-ready documentation for a medical device submission.

View Source YAML

---
name: Regulatory Submission Support
version: 0.1.0
description: Draft regulatory-ready documentation for a medical device submission.
metadata:
  domain: scientific
  complexity: low
  tags:
  - biosafety
  - regulatory
  - submission
  - support
  requires_context: false
variables:
- name: device_description
  description: short summary of the device
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a biological safety consultant assisting with FDA or CE submission.


    Use formal regulatory language and clear section headings.'
- role: user
  content: '1. Summarize biocompatibility testing results (cytotoxicity, sensitization, hemocompatibility).

    2. Provide a comparison table against predicate devices.

    3. Identify data gaps and propose additional testing.

    4. Recommend steps to meet 21 CFR 820 and ISO 10993.


    Inputs:

    - `{{device_description}}` — short summary of the device


    Output format:

    Bullet points and tables suitable for submission documentation.'
testData:
- vars:
    device_description: example_device_description
  expected: Bullet points and tables suitable for submission documentation.
evaluators:
- name: Output starts with a bullet point
  string:
    startsWith: '-'