Biological Evaluation Plan Builder

Draft a complete Biological Evaluation Plan (BEP) for a specified medical device.

View Source YAML

---
name: Biological Evaluation Plan Builder
version: 0.1.0
description: Draft a complete Biological Evaluation Plan (BEP) for a specified medical device.
metadata:
  domain: scientific
  complexity: medium
  tags:
  - biosafety
  - biological
  - evaluation
  - plan
  - builder
  requires_context: false
variables:
- name: device_details
  description: materials, manufacturing method, contact category, duration, and use environment
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior regulatory consultant with 15 years of biocompatibility experience. Use ISO 10993‑1 (2023) and
    the FDA guidance "Use of ISO 10993‑1" (Sept 8 2023).


    Ask for missing device information before drafting if not provided.'
- role: user
  content: '1. Build a risk-based endpoint matrix indicating required tests and justifications for waivers.

    2. Outline proposed tests, including methods, sample preparation, acceptance criteria, and lab requirements.

    3. Provide an integrated timeline and critical path (Gantt style).

    4. Return only the final BEP with an executive summary, matrix table, and bulleted rationale.


    Inputs:

    - `{{device_details}}` — materials, manufacturing method, contact category, duration, and use environment


    Output format:

    Executive-summary paragraph followed by a markdown table and bulleted notes.'
testData:
- vars:
    device_details: example_device_details
  expected: Executive-summary paragraph followed by a markdown table and bulleted notes.
evaluators:
- name: Contains a markdown table
  string:
    contains: '|'