In the interest to ensure safety and efficacy of the Medical Device, risk management is a stringent requirement for global Regulatory agencies. ISO14971 is the global standard of medical device risk management for manufacturers. 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.
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.
- Medical Device Risk Management Consulting
- Transition from ISO 14971:2007 to ISO 14971:2019 edition
- In-depth Gap Analysis for current procedures and risk management documents
- Preparation of comprehensive remediation plan
- Development of complete ISO 14971 Risk Management document and procedure system
- Support for individual critical elements of whole system like, Risk Analysis, Post-market Surveillance, etc.
- Qualified pool of experts with focus on identifying and reducing risk in multiple kinds of devices
- Experienced in executing multiple projects for implementation of QSR, MDSAP and ISO 13485 quality systems for various range of device classifications
- In-depth knowledge on specific product categories with coverage of wide functional and technical aspects of device to support 360-degree coverage of risk assessment