Overview
ISO 14971 is the international standard for risk management applicable to medical devices. It establishes a systematic approach for manufacturers to identify hazards, estimate and evaluate risks, control these risks, and monitor the effectiveness of controls throughout the product lifecycle.
Key Requirements
The standard requires a documented risk management process, risk analysis for each identified hazard, risk evaluation against acceptance criteria, risk control measures, and ongoing monitoring through production and post-production phases.
Benefits
Implementing ISO 14971 helps ensure patient safety, meet regulatory requirements globally, make informed design and development decisions, and create a defensible position regarding due diligence in managing risks.
Our Approach
Neural Vibe's implementation of ISO 14971 integrates with your existing development processes, automating risk analysis activities and providing traceability between hazards, risk controls, and verification activities.
Key Benefits
Enhanced Patient Safety
Systematically identifies and mitigates risks that could harm patients, ensuring safer medical devices.
Example: Organizations implementing ISO 14971 report significantly fewer safety-related incidents and recalls.
Regulatory Compliance
Satisfies risk management requirements across major regulatory frameworks including FDA and EU MDR.
Example: ISO 14971 compliance is explicitly required by EU MDR and recognized by FDA as best practice.
Design Decision Support
Provides structured framework for making informed design decisions based on risk-benefit analysis.
Example: Risk analysis helps prioritize safety features and justify design choices to regulatory authorities.
Liability Protection
Demonstrates due diligence in risk management, providing legal protection against safety-related claims.
Example: Comprehensive risk management documentation supports defensibility in product liability cases.
ISO 14971 Implementation Process
Building Your Medical Device Risk Management System
Risk Management Planning
Establish a comprehensive risk management plan defining activities, responsibilities, and criteria for risk acceptability.
Risk Analysis
Identify and analyze potential hazards associated with your medical device throughout its lifecycle.
Risk Evaluation
Estimate and evaluate risks for each hazard, determining which require risk control measures.
Risk Control Implementation
Design and implement risk control measures to reduce risks to acceptable levels.
Residual Risk Evaluation
Evaluate the effectiveness of risk controls and assess remaining residual risks.
Risk/Benefit Analysis
Perform risk/benefit analysis for residual risks that exceed acceptance criteria.
Risk Management Review
Conduct comprehensive review of the risk management process and prepare documentation for regulatory submission.
Explore Other ISO Standards We Support
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