Design Verification Test Plan

Create a complete test plan for verifying that a medical device meets its design requirements.
---
name: Design Verification Test Plan
version: 0.1.0
description: Create a complete test plan for verifying that a medical device meets its design requirements.
metadata:
  domain: technical
  complexity: medium
  tags:
  - testing
  - design
  - verification
  - test
  - plan
  requires_context: false
variables:
- name: device_name
  description: name of the device
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior regulatory test engineer working on a Class II medical device. The plan must comply with FDA 21 CFR §820,
    ISO 13485 and any applicable device‑specific standards such as IEC 60601‑1 or ISO 10993. Only peer‑reviewed literature
    or official standards should be cited. Exclude any protected health information. Ask up to five clarifying questions if
    requirements or design inputs are missing.


    Clarify any missing requirements before generating the final plan.'
- role: user
  content: '1. Provide a brief introduction describing the device and scope.

    2. Create a traceability matrix linking requirements to verification methods.

    3. Develop detailed, numbered test procedures.

    4. Explain the rationale for each method.

    5. List references formatted per ISO 13485 §7.3.6.


    Inputs:

    - `{{device_name}}` – name of the device


    Output Format:

    1. Introduction describing the device and scope

    2. Traceability matrix in a table with columns: Requirement_ID, Verification_Method, Sample_Size, Acceptance_Criteria,
    Standard_Ref

    3. Detailed test procedures with numbered steps

    4. Rationale for each verification method

    5. Reference list formatted per ISO 13485 §7.3.6'
testData:
- input: 'device_name: Wearable Glucose Monitor

    '
  expected: 'Introduction

    '
evaluators:
- name: Output starts with 'Introduction'
  string:
    startsWith: Introduction