ISO 14971 is the international standard for risk management of medical devices (including in vitro diagnostics and software as a medical device). It provides a systematic process to identify hazards, estimate and evaluate risks, implement risk controls, and monitor the effectiveness of those controls throughout the product’s lifecycle.
It is required or strongly referenced by regulators worldwide (FDA, EU MDR, UK MHRA, TGA, Health Canada, etc.), and it is tightly linked to ISO 13485 (quality management systems for medical devices).
What Is Risk Management in a Medical Device Context?
Risk management is the process of:
Identifying hazards
Determining risk (severity × probability)
Controlling risk
Ensuring the benefits outweigh residual risks
Monitoring risk post-market
In medical devices, “risk” refers to harm to the patient, user, or environment, not business or financial risk.
Examples of risks:
Electrical shock from a faulty infusion pump
Incorrect reading from diagnostic software
Biocompatibility issues from an implant
Software malfunction leading to incorrect therapy delivery
What ISO 14971 Covers
ISO 14971 gives manufacturers a framework for performing risk management, including:
1. Risk Management Plan
Before any assessment begins, you must define:
Scope of the device
Responsibilities
Risk acceptability criteria
Methods / tools
Post-market activities
2. Hazard Identification
You must consider all types of hazards:
Biological (toxicity, contamination)
Mechanical (breakage, moving parts)
Electrical
Software (algorithm errors, cybersecurity)
Usability / human factors
Radiation, thermal, chemical
3. Risk Analysis
Determine:
Sequence of events that could lead to harm
Severity of harm
Probability of occurrence
4. Risk Evaluation
Compare the risk levels to your predefined acceptability criteria.
5. Risk Control
If a risk is unacceptable, implement controls:
Inherent safety by design (best)
Protective measures (guards, alarms, redundancy)
Information and training (least effective)
After controls are applied:
Estimate residual risk
Ensure each is acceptable
Conduct a risk/benefit analysis if not
6. Evaluation of Overall Residual Risk
Even if individual risks are acceptable, the overall residual risk must also be acceptable.
7. Production and Post-Market Monitoring
Risk management is continuous:
Complaint analysis
Field reports
Clinical follow-up
CAPA (Corrective and Preventive Action)
Trend analysis
Why ISO 14971 Matters
Regulatory
EU MDR and IVDR require full compliance with ISO 14971.
FDA recognizes and recommends its use.
Essential for CE marking, UKCA, TGA, and Health Canada approval.
Operational
Prevents harm to patients and users
Reduces recalls, complaints, and liability
Drives safer design through systematic thinking
Business
Required for most international markets
Integrates tightly with ISO 13485 QMS
Supports faster regulatory submission and smoother audits
Example: Applying ISO 14971 to a Device
Device: Blood glucose meter
Hazard: Software miscalculates glucose level
Severity: High (could cause incorrect insulin dosing)
Probability: Medium
Risk Controls:
Algorithm validation
Redundant checks
Alerts for out-of-range sensor values
Clear UI to prevent user error
Residual Risk: Acceptable only if probability is reduced sufficiently and user information is provided.
Relationship to Other Standards
ISO 13485 – requires risk management throughout design and manufacturing
IEC 62304 – software lifecycle; uses ISO 14971 for software risk management
IEC 60601-1 – electrical safety; references ISO 14971
IEC 62366 – usability engineering; addresses use-related risks
In One Sentence
ISO 14971 is the globally accepted framework that ensures medical devices are designed, produced, and monitored with risks controlled to protect patients and users throughout the entire device lifecycle.
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