ISO 14971 Risk Management
ISO 14971:2007 is the current international standard for risk management for medical devices. It is recognized by the U.S., European Union, and Canada as a means to establish, document, and maintain a risk management program that complies with FDA, EU and Health Canada requirements. ISO 14971 outlines the risk management requirements to:
- Review a product's intended use
- Identify and quantify any potential hazards during the design and development process
- Mitigate risks to a acceptable level and affirm the acceptability of risk prior to marketing a device.
- Establish processes to monitor products post market and take action if risks are greater than expected or new risks arise.
Integrating risk management into your quality system can be challenging. Identifying risks is an integral part of the design and development process. Risk needs to be addressed throughout the entire medical device product life cycle - when handling complaints, taking corrective or preventive action and selecting suppliers.
MDCI will help you to assess your current level of compliance and design, implement, and establish a risk management program that will best comply with ISO 14971:2007, or allow you to manage, monitor and assess risk at all stages, from the design process, to manufacture and commercialization, through postmarket surveillance.
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