Closing The Loop: Using Your Post-Market Surveillance System To Feed Your Risk Management And Product Lifecycles
- Recognizing that medical device risk management is not a one-time project, but rather an ongoing process of review and risk assessment throughout the life of the device
- Developing a systematic process to evaluate products on a continuing basis
- Analyzing feedback to determine whether corrective and preventative action needs to be taken to fix the problem
- Determining if changes must be made to the original medical device risk assessment