ISO 14971 Risk Management Consulting

It has officially been recognized by the United States Food and Drug Administration (US FDA), Health Canada (HC), Therapeutic Goods Administration (TGA), Australia, and the Pharmaceuticals and Medical Devices Agency (PMDA), Japan as the risk management standard for medical devices, and it is an integral component of risk management systems compliant with ISO 13485. In addition, the European Union (EU) has adopted it as a harmonized standard.

The standard has been revised in 2019, and manufacturers shall update their existing risk management systems and documents to comply with this third edition of the standard.

The standard specifies terminologies and processes of risk management for medical devices, SaMD, and In Vitro Diagnostics (IVDs). The ISO 14971 medical device risk management standard supports medical device manufacturers in identifying the hazards associated with medical devices, to estimate and evaluate the associated risks, control the risks, and monitor the efficacy of the controls.

ISO 14971 consulting includes:

• Risk management process.
• Assigning qualified personnel.
• Establishing a risk management framework.
• Undertaking risk analysis and estimating the risk for each hazardous situation.
• Evaluating the risk for each identified hazardous situation.
• Developing risk control measures when risk must be reduced.
• Evaluating the acceptability of the overall residual risk.
• Carrying out a risk management review and preparing a risk management report.
• Establishing a monitoring system for the production and post-production phases.

Freyr’s pool of experts offers medical device risk management consulting services for planning risk management activities, establishing a risk management system, conducting gap analysis, ensuring compliance with the ISO 14971:2019 edition, and creating compliant risk management files.