Worst-Case Device & Test-Article Selection Starter
Frame one biological question, compare no more than four device candidates, and expose the facts and evidence a qualified reviewer still needs before any selection or protocol approval.
Tool at a glance
One Biological Question
Keep the comparison decision-specific because a different question may require a different candidate or evidence route.
Up to 4 Candidates
Register controlled facts for materials, process, surface, sterilization, ageing, geometry, contact, and use.
10 Challenge Dimensions
Record support, limitations, and unknowns without turning dissimilar factors into a universal rank or score.
Replace “largest device” shorthand with a question-specific record
A candidate may bound one material, surface, geometry, extraction, or exposure consideration without bounding every biological question. This starter keeps the question, candidate set, evidence, exceptions, and approval boundary visible.
Define one decision
Record the biological question, device family, final-finished reference, use, population, contact, route, market, and accountable reviewers.
Register candidates
Compare up to four named configurations using controlled material, process, sterilization, packaging, ageing, geometry, contact, and source facts.
Challenge the dimensions
Review question-specific differences in composition, processing, surface, exposure, degradation, extraction, contact, and clinical factors.
Control a proposal
Record the proposed relationship, limitations, exclusions, bridging evidence, remaining unknowns, protocol dependencies, and required approval.
Do not overclaim
The starter never selects or authorizes a test article, declares universal worst case, establishes equivalence, or prescribes extraction.
For a complete comparison and approval system, use the Device-Family & Worst-Case Justification Pack. Use the Test Strategy & Test-Article Preparation Pack when the work extends into laboratory handoff, or a submission gap review when the evidence relationship is already embedded across files.
Get Version 1.0
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Best For
- Device-family and configuration comparison planning
- Test-article proposal preparation before qualified review
- Evidence-gap and laboratory-handoff discussions
What Happens Next
- Download the eight-page interactive PDF
- Define one biological question and no more than four candidates
- Take the supported comparison and open unknowns to qualified approval
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