ISO 14971:2007 Consultants for Risk Management
ISO 14971 is an international standard for risk management of medical devices. It is recognized by the US Food and Drug Administration (FDA), Europe, Canada and Australia as the “de facto” standard for risk management. ISO 14971:2007 is an integral part of a quality system and should be incorporated into the design and development process. The purpose of ISO 14971 is to establish, document and maintain a risk management process to:
- 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 that adopting ISO 14971 is fairly painless. This standard supersedes EN 1441 and requires you to review 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 included during your annual internal audit. Risk Assessments need to state the frequency of the review and the data that will be reviewed.
Why you should choose Emergo Group as your ISO 14971 consultants for medical device risk management
- We specialize in quality assurance for medical device and IVD companies.
- We understand medical device manufacturing processes. Our consulting team has implemented hundreds of GMP and ISO 13485 quality systems at medical device companies making a wide range of Class I, II and III devices.
- Our experienced team of Certified Lead Assessors is skilled at identifying and reducing risk in all types of devices and processes.
- We have extensive experience integrating ISO 14971:2007 risk management into existing ISO 13485 and GMP quality systems.
- Emergo Group is widely respected in the industry for providing high quality consulting work to medical device companies.
- You will have secure online access to all of your documentation through the Emergo Group website at no additional cost.
Contact us today for a free consultation for ISO 14971 implementation support.
