Regulatory Gap-Analysis Comparator

Compare sterility-assurance requirements across key standards and guidance.

View Source YAML

---
name: Regulatory Gap-Analysis Comparator
version: 0.1.0
description: Compare sterility-assurance requirements across key standards and guidance.
metadata:
  domain: scientific
  complexity: medium
  tags:
  - sterility
  - regulatory
  - gap-analysis
  - comparator
  requires_context: false
variables:
- name: device_description
  description: brief description of the device
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a regulatory-affairs consultant analyzing a Class III implantable device sterilized with vapor-phase hydrogen
    peroxide.


    Compare sterility-assurance requirements across key standards and guidance.'
- role: user
  content: '- Build a comparison table with rows for key topics—validation approach, load configuration, SAL definition, pyrogenicity,
    reprocessing, and labeling—and columns for each document: FDA *Submission and Review of Sterility Information* (8 Jan 2024
    update), **ISO 11137‑1:2025**, **ISO 22441:2022**, and **ISO 11737‑2:2019**.

    - Highlight any **gaps or divergences** and flag items required in a 510(k).

    - Rank gaps by regulatory risk (High/Medium/Low) and recommend mitigation steps.


    Inputs:

    - `{{device_description}}` – brief description of the device.


    Output format:

    Markdown table followed by a short executive summary (≤ 200 words).


    Additional notes:

    - Use bold red text `**<text>**` for high‑risk gaps.

    - Do not expose your chain of thought.'
testData:
- vars:
    device_description: example_device_description
  expected: Markdown table comparing sterility requirements with a brief executive summary.
evaluators:
- name: Output starts with table row
  string:
    startsWith: '|'
- name: Contains summary section
  string:
    contains: Summary