Risk Pack Generator

Generate ISO 14971-compliant risk management starter kits with hazard analysis frameworks and control measure templates. This free tool saves consultants 4-6 hours per device by automatically creating risk management document structures, hazard identification frameworks, and risk control measure templates.

How It Works

The Risk Pack Generator creates comprehensive risk management frameworks:

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Hazard Identification Framework: Generates device-specific hazard identification frameworks based on device type, intended use, and technological characteristics, covering electrical, mechanical, biological, software, and use-related hazards.
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Risk Analysis Templates: Creates structured risk analysis templates with severity and probability assessment scales, risk matrix frameworks, and risk estimation methodologies per ISO 14971 requirements.
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Control Measure Identification: Identifies applicable risk control measures including design controls, protective measures, information for safety, and post-production monitoring requirements.
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Residual Risk Assessment: Provides frameworks for evaluating residual risks after implementation of control measures and determining acceptability per ISO 14971 criteria.
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Document Structure: Generates complete risk management file structure with sections for risk management plan, risk analysis, risk evaluation, risk control, and production/post-production monitoring.

What It Does

This tool generates comprehensive risk management starter packs:

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Risk Management Plan Template: Complete ISO 14971-compliant risk management plan structure with device-specific sections
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Hazard Analysis Framework: Device-specific hazard identification framework with common hazards for the device type
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Risk Control Templates: Structured templates for documenting risk control measures with traceability to hazards
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Risk Matrix Tools: Customizable risk matrices and assessment scales for severity and probability evaluation
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Exportable Pack: Professional PDF risk management starter pack with your branding that can be customized for specific devices

⏱️ How It Saves Time

Saves 4-6 hours per device by automating risk management framework creation:

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Framework Generation: Eliminates 2-3 hours of manually creating risk management document structures and templates
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Hazard Identification: Saves 1-2 hours of researching and identifying device-specific hazards and failure modes
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Control Measure Templates: Automates 1-2 hours of creating risk control measure templates and documentation structures
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ISO 14971 Compliance: Ensures compliance with ISO 14971 structure requirements, saving 30-60 minutes of compliance review

ROI: for FDA 510k Consultants developing 5+ risk management files per month, this tool saves 20-30 hours monthly while ensuring ISO 14971 compliance.

Perfect For

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FDA 510k consultants developing ISO 14971 risk management files for medical devices
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Regulatory teams creating risk management documentation for 510(k) submissions
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Firms providing risk management consulting services to medical device companies
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FDA 510k consultants reviewing and updating existing risk management files

Need ISO 14971 expertise?

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Get Free Access to Risk Pack Generator

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