ISO 14971:2019 Compliance Made Simple
The Complete Risk Management Toolkit for Medical Devices
6 professionally crafted, audit-ready document templates that bring your risk management process into full compliance with ISO 14971:2019.
Why Risk Management Documentation Matters
Incomplete or non-compliant risk management files are the #1 reason for FDA 510(k) delays and EU MDR rejections. Don't let documentation gaps stall your device launch.
Audit-Ready
Every template maps directly to ISO 14971:2019 clauses, so you pass audits the first time.
Save 40+ Hours
Skip months of research and drafting. Start with proven templates used by 500+ companies.
Regulatory Confidence
Designed by compliance professionals with decades of FDA and EU MDR submission experience.
What's Inside the Toolkit
6 meticulously structured documents covering every stage of the ISO 14971 risk management process.
Risk Management Plan Template
Comprehensive plan aligned with ISO 14971:2019 Clause 4.4. Defines scope, roles, criteria, and lifecycle activities.
Risk Analysis FMEA Form
Failure Mode and Effects Analysis worksheet with severity, probability, and detectability scoring matrices.
Risk Evaluation Worksheet
Systematic evaluation against predefined acceptability criteria with clear accept/mitigate/reject decision framework.
Risk Control Measures Log
Track risk control options, implementation status, and verification of effectiveness per Clause 7.
Residual Risk Assessment
Document and evaluate residual risks after controls are applied. Includes overall residual risk analysis.
Risk Management Report Template
Final summary report template covering the entire risk management process with regulatory submission readiness.
Trusted by Regulatory Professionals
“These templates cut our ISO 14971 compliance prep from 3 months to 3 weeks. The FMEA form alone saved us hundreds of hours.”
Dr. Sarah Chen
VP of Quality, MedTech Innovations
“We used this toolkit for our 510(k) submission. The auditor specifically praised our risk management documentation.”
Michael Torres
Regulatory Affairs Director, CardioSense Inc.
“Finally, risk management templates that actually reflect the 2019 revision. Worth every penny for the time savings alone.”
Jennifer Park
Quality Systems Manager, NovaBio Devices
Get Compliant Today
Join 500+ medical device companies who trust our ISO 14971 templates for their risk management documentation.
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