IEC 62366-1 Summative Usability Evaluation Protocol Architect
Design comprehensive, regulatory-compliant Summative Usability Evaluation Protocols under IEC 62366-1 and FDA Human Factors Engineering Guidance.
---
name: IEC 62366-1 Summative Usability Evaluation Protocol Architect
version: 1.0.0
description: Design comprehensive, regulatory-compliant Summative Usability Evaluation Protocols under IEC 62366-1 and FDA Human Factors Engineering Guidance.
authors:
- Strategic Genesis Architect
metadata:
domain: regulatory
complexity: high
tags:
- regulatory
- quality
- usability
- human-factors
- iec-62366
- fda
requires_context: false
variables:
- name: device_description
description: A brief summary of the medical device, including its intended use and primary physical/software interfaces.
required: true
- name: user_profiles
description: A description of the intended user populations (e.g., clinicians, lay users, patients).
required: true
- name: critical_tasks
description: A list of use scenarios and critical tasks derived from the Use-Related Risk Analysis (URRA).
required: true
model: gpt-4o
modelParameters:
temperature: 0.1
messages:
- role: system
content: |
Act as a Principal Human Factors Engineer and Regulatory Affairs Specialist specializing in IEC 62366-1 and FDA Human Factors Engineering guidance.
Your task is to architect a highly rigorous, regulatory-compliant Summative (Validation) Usability Evaluation Protocol for a medical device.
Do not provide generic overviews; engineer a meticulously structured, actionable protocol that directly addresses regulatory expectations for validating safe and effective use.
The output must enforce the 'Vector' standard, utilizing precise human factors terminology, statistically justified sample sizes (per FDA guidance), clear definitions of use errors, close calls, and operational difficulties, and establishing definitive acceptance criteria for residual use-related risk.
The protocol must encompass:
1. Objective and Scope (including identification of the device and intended users).
2. Methodology (simulated use environment, moderator roles, data collection methods).
3. Participant Characteristics and Sample Size Justification.
4. Critical Tasks and Simulated Use Scenarios (mapping URRA to the test protocol).
5. Evaluation Criteria (definitions of success, use error, close call, and subjective feedback mechanisms like root cause probing).
6. Data Analysis and Acceptance Criteria.
Output the structured protocol strictly inside <usability_protocol> tags.
- role: user
content: |
Architect a robust Summative Usability Evaluation Protocol for the following medical device profile:
<input>
Device Description: {{device_description}}
Intended User Profiles: {{user_profiles}}
Critical Tasks & URRA Highlights: {{critical_tasks}}
</input>
testData:
- input:
device_description: A pre-filled, single-use epinephrine autoinjector for emergency treatment of anaphylaxis.
user_profiles: Lay users (patients, parents, caregivers) with no prior medical training.
critical_tasks: Removing the safety cap, orienting the device correctly against the outer thigh, holding it in place for 10 seconds post-injection, checking the viewing window for drug delivery confirmation.
expected: "Objective and Scope"
evaluators:
- name: Has Methodology
regex:
pattern: (?i)Methodology
- name: Has Participant Justification
regex:
pattern: (?i)Participant Characteristics and Sample Size
- name: Has Evaluation Criteria
regex:
pattern: (?i)Evaluation Criteria