What is ISO 14971:2007?
- Estimate and evaluate risks
- Control risks
- Monitor risk control effectiveness
There are many risks associated with the design & production of Medical Devices but also in their use. Risk to safety of patients, users, handlers and Regulatory Product liability must all be managed. Manufacturers must conduct and document a risk management process.
- Buy ISO 14971:2007 – Application of Risk Management to Medical Devices
|Tools to help with Risk Management:|
ISO Guide 73 – Risk management vocabulary
Risk Management Exercise and PowerPoint
Risk Management Procedure
ISO 14971 is recognized by:
- The U.S. Food and Drug Administration (FDA)
- The EU has harmonized with European Medical Devices Directive 93/42/EEC.
- ISO 13485 refers to ISO 14971 for guidance related to risk management.
Download a free presentation:
How are ISO 14971 and ISO 13485 related?
The two standards work together and are related. ISO 13485 is focused on regulatory and customer requirements and for medical devices. As ISO 13485 requires risk analysis and record keeping pertaining to any risk, ISO 13485 looks to ISO 14971 for guidance. ISO 14971 is more detailed when it comes to risk management requirements.
Risk Management Plan in your organization
ISO 14971 provides a framework of risk management activities as applied to medical devices. From initial analysis to risk control & evaluation, the probability and frequency of harm can be assessed, analyzed & managed.
Risk Analysis and Management Plan
Create a mitigational plan outlining your risk management program, the required resources, and the training/experience of the those calculating the risks. Measure and monitor processes as required in ISO 13485.
As required in ISO 13485, management commitment and involvement is essential. Risk objectives are part of the organization’s goals and resources must be allocated to properly mitigate risk.
ISO 14971 requires medical device manufacturers to consider all possible negative consequences resulting from use of their device. There are several ways to identify the risks in medical devices, then you estimate it’s probability and impact as defined in the standard.
Determine ways to minimize risk to an acceptable level, which must be clearly communicated to all stakeholders.