Standards Compliance Checklist

Automatically identify all required and recognized consensus standards for your device with purchase links and cost estimates. This free tool saves consultants 2-3 hours per device by compiling comprehensive standards checklists from FDA databases and special controls.

How It Works

The Standards Compliance tool identifies applicable standards:

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Product Code Analysis: Identifies all consensus standards referenced in FDA special controls, recognition orders, and device-specific guidance documents for the device's product code.
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Standards Database Search: Searches FDA's Recognized Consensus Standards database to identify ISO, IEC, ASTM, AAMI, and other standards applicable to the device type, materials, and testing requirements.
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Version Identification: Identifies current versions of standards and any version-specific requirements, ensuring compliance with FDA-recognized standard versions.
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Purchase Links: Provides direct links to standards organizations (ISO, IEC, ASTM, AAMI) for purchasing standards, including pricing information and subscription options.
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Cost Estimation: Calculates total cost estimates for purchasing required standards, helping clients budget for standards compliance.

What It Does

This tool generates comprehensive standards compliance reports:

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Standards Checklist: Complete list of all required and recognized standards, organized by category (biocompatibility, electrical safety, software, sterilization, etc.)
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Purchase Information: Direct links to purchase standards, pricing, and subscription options from standards organizations
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Version Requirements: Current FDA-recognized versions of each standard and any version-specific compliance requirements
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Cost Summary: Total estimated cost for purchasing all required standards, helping clients budget for compliance
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Exportable Report: Professional PDF checklist with your branding that can be shared with clients or included in regulatory documentation

⏱️ How It Saves Time

Saves 2-3 hours per device by automating standards research:

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Automated Standards Identification: Eliminates 1-2 hours of manually searching FDA databases and special controls to identify applicable standards
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Version Research: Saves 30-60 minutes of identifying current FDA-recognized versions of standards and checking for updates
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Purchase Link Compilation: Automates 30-60 minutes of finding and compiling purchase links and pricing information from multiple standards organizations
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Checklist Generation: Provides ready-made checklist structure, saving 30-60 minutes of document creation and formatting

ROI: for FDA 510k Consultants handling 10+ devices per month, this tool saves 20-30 hours monthly while ensuring comprehensive standards identification.

Perfect For

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FDA 510k consultants preparing standards compliance assessments for medical devices
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Regulatory teams identifying required standards for testing programs
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Firms providing regulatory strategy services with standards budgeting
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FDA 510k consultants reviewing client standards compliance for completeness

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Get Free Access to Standards Compliance Checklist

This tool is completely free for verified FDA 510k consultants in the Cruxi network. Join thousands of regulatory professionals who use our tools to save 20+ hours per week.

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✓ No subscription fees • ✓ All 15 tools included • ✓ Export with your branding