A medical device must be safe for its intended purpose. ISO 14971 provides a structured risk management assessment process intended to help medical device manufacturers ensure that their products are safe for their intended use. ISO 14971 is a state-of-the-art, international standard that is quickly being recognized as the best structure to ensure that all aspects of risk management are considered throughout the product lifecycle of all medical devices regardless of their classification.

ISO 14971 assists medical device manufacturers in establishing, documenting and maintaining a risk management process to:

• Review a product’s intended use;
• Identify hazards and hazardous conditions during the design & development process;
• Estimating and evaluating associated risks;
• Controlling and/or mitigating those risks, and
• Continually monitoring the effectiveness of the controls put in place throughout the product life cycle and take action if risks are greater than expected or new risks arise.

• Work with your management team to develop and implement a risk management process that will help your company ensure their products are safe for their intended use
• Facilitate the risk management process
• Organize and document your processes and systems
• Assist you in implementing support processes
• Develop methods to measure and monitor risk management processes
• Assist you in integrating this management system into others you may already have.