ISO 14971 Risk Management Consulting

Overview

In the interest to ensure safety and efficacy of the Medical Device, risk management is a stringent requirement for global Regulatory agencies. ISO 14971 is a widely accepted standard for risk management practices. It has officially been recognised by USFDA, Health Canada, TGA (Australia) and PMDA (Japan) as the risk management standard for medical devices and is an integral component of risk management system compliant with ISO 13485.In addition, European Union has adopted it as a harmonized standard.

 The standard has been revised in 2019 and the manufacturers shall update their existing Risk Management Systems and documents to comply with this third edition of the standard.

The standard specifies terminologies and process of risk management for medical devices, SaMD and In-vitro diagnostics. ISO 14971 Medical Device Risk Management standard supports the Medical Device manufacturers to identify the hazards associated with the Medical Device, to estimate and evaluate the associated risks, to control the risks and to monitor the effectiveness of the controls. The Risk Management shall span throughout the device life cycle from designing phase to commercialization, production, and post-production phases. 

Comprehensive risk assessment program helps to deal with design issues before launching the device in market, eliminating dangerous problems and the costs associated with recalls.

The High-level ISO 14971 Medical Device Risk Management Standards are

• Risk management process
• Assignment of qualified personnel
• Establish risk management framework 
• Undertake risk analysis and estimate the risk for each hazardous situation
• Evaluate the risk for each identified hazardous situation 
• Develop risk control measures when risk must be reduced 
• Evaluate the acceptability of the overall residual risk 
• Carry out a risk management review and prepare a risk management report
• Establish a monitoring system for production and post-production phases

Freyr’s expert pool offers Medical Device Risk Management consulting services for planning the risk management activities, establishment of a risk management system, gap analysis, compliance with ISO 14971:2019 edition and creation of compliant Risk Management files.