$247 — Standard Tier

ISO 14971 Risk Management Toolkit: Risk Analysis, FMEA & Benefit-Risk

Complete ISO 14971:2019 risk management file templates. Risk analysis, dFMEA, pFMEA, benefit-risk analysis, and production monitoring. FDA and EU MDR compliant.

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What's Included

Risk Management Plan Template
Risk Analysis Worksheet (ISO 14971)
Design FMEA (dFMEA) Template
Process FMEA (pFMEA) Template
Risk Evaluation Matrix
Risk Control Measures Tracking
Benefit-Risk Analysis Template
Risk Management Report Template

Benefits

Complete risk management file ready for submission
ISO 14971:2019 compliant structure
Accepted by FDA, EU Notified Bodies, and MDSAP auditors
Integrated with design controls workflow

Is This For You?

This toolkit is designed for teams facing these challenges:

Risk file is incomplete or outdated
Unsure how to structure benefit-risk analysis
FMEA templates don't meet FDA expectations
Risk management not integrated with design process

Who This Is For

Any medical device manufacturerRA/QA professionals building risk filesCompanies preparing for regulatory submission

Frequently Asked Questions

Is this the 2019 version of ISO 14971?

Yes, fully aligned with ISO 14971:2019 and ISO/TR 24971:2020.

Does this cover software risks?

Yes, includes considerations for SaMD. For IEC 62304, see our SaMD Toolkit.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $247

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