| Criteria | ISO 14971 | ISO 13485 | Remarks |
| Standard Type | Risk Management Standard for medical devices | Quality Management System (QMS) standard for medical devices | ISO 14971 = risk-specific; ISO 13485 = overall QMS framework |
| Primary Focus | Identification, evaluation, control, and monitoring of risks associated with medical devices | Establishes a QMS framework ensuring design, production, and distribution of safe medical devices | ISO 14971 ensures safety through risk analysis; ISO 13485 ensures consistent QMS application |
| Scope | Risk management throughout product lifecycle (design → production → post-market) | Quality management covering design, manufacturing, regulatory compliance, and documentation | ISO 14971 = risk-centric; ISO 13485 = process/system-centric |
| Application | Applied to risk assessment processes, e.g., hazard identification, risk evaluation, risk/benefit analysis | Applied to company-wide QMS, including design control, traceability, CAPA (Corrective and Preventive Action) | Both work together for regulatory approval |
| Regulatory Relevance | Referenced by FDA, EU MDR, and other regulatory bodies for risk management compliance | Required for CE marking (EU), FDA recognition, and international compliance | ISO 14971 is often used within ISO 13485-based QMS |
| Documentation | Risk management file (RMF), risk analysis reports, benefit–risk evaluations | Quality manual, procedures, device master record, audit records | ISO 14971 output feeds into ISO 13485 documentation |
| Relation Between Standards | Provides risk management process that is integrated into ISO 13485 QMS | Provides QMS framework that incorporates ISO 14971-based risk management | Complementary: ISO 14971 = “how to manage risks”; ISO 13485 = “how to run QMS” |
| End Goal | Minimize potential harm to patients/users through structured risk processes | Ensure safe, effective, and consistent medical device production | Both work synergistically for regulatory approval and patient safety |
