Test Evidence Planner

How It Works

The Test Evidence Planner analyzes device attributes to generate testing requirements:

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  Device Attribute Analysis: Evaluates device characteristics including device class, product code, patient contact, sterility, electrical components, software level, and intended use to determine applicable testing requirements.
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  Testing Category Identification: Automatically identifies required testing categories such as biocompatibility, electrical safety, software validation, cybersecurity, human factors, performance testing, and clinical evaluation based on device attributes.
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  Standards Mapping: Links testing requirements to specific consensus standards (ISO, IEC, ASTM) that must be met, including version numbers and testing methods.
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  Regulatory Justification: Provides regulatory justifications for each testing requirement, citing special controls, FDA guidance documents, and CFR sections that mandate the testing.
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  Prioritized Checklist: Organizes testing requirements by priority (critical, high, medium, low) and testing phase to help consultants plan testing programs efficiently.

What It Does

This tool generates comprehensive evidence planning reports:

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  Testing Checklist: Complete, prioritized list of all required testing organized by category (biocompatibility, electrical safety, software, performance, etc.)
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  Standards Requirements: All applicable consensus standards with version numbers, testing methods, and purchase links
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  Regulatory Justifications: Detailed explanations of why each test is required, with citations to special controls, guidance documents, and CFR sections
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  Testing Timeline Framework: Suggested testing sequence and dependencies to help plan efficient testing programs
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  Exportable Report: Professional PDF testing plan with your branding that can be shared with clients or testing laboratories

Perfect For

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  FDA 510k consultants developing testing plans and evidence strategies for medical devices
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  Regulatory teams identifying required testing for new device development programs
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  Firms providing testing planning services to medical device companies
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  FDA 510k consultants reviewing client testing programs for completeness and compliance

Need a testing partner?

If you need labs or regulatory experts to execute the plan, compare providers in the Cruxi directories hub.