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The Comprehensive ISO 14971 Handbook

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What is ISO 14971, and why it's important?

ISO 14971 is the international standard for risk management of medical devices. It provides a systematic framework for identifying hazards, estimating and evaluating risks, implementing risk control measures, and monitoring the effectiveness of those measures throughout the medical device lifecycle.

Risk management in medical devices is crucial because it directly impacts patient safety, product quality, and regulatory compliance. Without a robust risk management process, manufacturers face challenges such as product recalls, regulatory penalties, and increased liability.

This whitepaper will explore:

ISO 14971 Risk Management Fundamentals - Understand core requirements and regulatory expectations.
Hazard Identification & Risk Analysis - Identify hazards and evaluate associated risks.
Risk Control & Residual Risk Evaluation - Implement controls and assess risk acceptability.
Lifecycle Risk Management - Manage risks from development through post-market.
Risk Traceability & Documentation - Link risks to requirements, design, and verification.
Digital Tools & Automation - Streamline workflows and improve audit readiness.