ISO 14971 is the international standard for the application of risk management to medical devices.
Complete Guide to ISO 14971
ISO 14971:2019 is the internationally recognized standard that specifies a process for manufacturers to identify hazards associated with medical devices, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of controls.
Key features of ISO 14971:
- Latest version: ISO 14971:2019 (published December 2019)
- Harmonized standard under EU MDR and IVDR
- Recognized by FDA and global regulators
- Lifecycle approach to risk management
- Risk-benefit analysis framework
Risk management process:
1. Risk Analysis
- Identify intended use and reasonably foreseeable misuse
- Identify hazards and hazardous situations
- Estimate risks for each hazardous situation
- 1Risk Evaluation
- 1Risk Control
- 1Production and Post-Production
Integration with FMEA:
- Failure Mode and Effects Analysis (FMEA) commonly used
- Risk Priority Number (RPN) calculation
- Design FMEA (DFMEA) and Process FMEA (PFMEA)
- Complements ISO 14971 systematic approach
Residual risk evaluation:
- All risks cannot be eliminated
- Residual risks must be evaluated for acceptability
- Risk-benefit analysis required
- Must be disclosed in labeling/instructions for use
Relationship to regulations:
- EU MDR/IVDR: Annex I requires compliance with ISO 14971
- FDA: Recognized consensus standard (guidance documents reference it)
- ISO 13485: Risk management integrated throughout QMS
- IEC 62304: Software risk management requirements
Risk management file:
- Living document updated throughout product lifecycle
- Contains risk analysis, evaluation, control, and monitoring
- Required for regulatory submissions (510(k), CE marking)
- Subject to audits and inspections
Related Terms
More Compliance & Standards
View allThe FDA's Quality System Regulation (QSR) that establishes current Good Manufacturing Practice (cGMP) requirements for medical device manufacturers in the United States.
A systematic, independent examination of a Quality Management System to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively.
A systematic approach to investigating, correcting, and preventing quality problems in medical device manufacturing and operations.
A mandatory conformity marking for medical devices sold in the European Economic Area, indicating compliance with EU health, safety, and environmental requirements.
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