- Review the intended use of the medical device.
- Identify hazards and estimate the probability that harm might occur.
- Estimate the severity of each hazard and evaluate the associated risks.
- Control those risks and monitor the effectiveness of the controls put in place.
Overall, most medical device companies find adopting ISO 14971 a challenge. This standard requires a review of the product's risk assessment over time to monitor any changes - from design changes to customer input/feedback, including post market surveillance. This can be done during management reviews and should also be part of your internal audit process. Risk assessments need to state the frequency of the review and the data that will be reviewed.
If you have already implemented an ISO 13485 quality management system, we can assist with integrating ISO 14971 with your existing quality management system.
Why choose Emergo as your ISO 14971 consultants for medical device risk management:
- We specialize in quality assurance for medical device and IVD companies.
- Our consulting team has implemented hundreds of FDA QSR and ISO 13485 quality systems at medical device companies making a wide range of Class I, II and III devices.
- Our experienced team of consultants is skilled at identifying and reducing risk in all types of devices and processes.
- We have extensive experience integrating EN ISO 14971:2012 into existing ISO 13485 and FDA GMP quality management systems.
- Emergo is widely known in the industry for providing high quality consulting to medical device companies.
Please contact us for more information on ISO 14971 consulting.