Risk Management Procedures

 Product liability and regulations have become critical issues for the medical device industry. For this reason, device manufacturers struggle to have a stringent process in place that could analyze, evaluate and control risks associated with the entire lifecycle of the product. ADB Consulting’s Risk Management Procedures incorporate complete criteria for identifying, planning, analyzing, evaluating and controlling the potential risks that may arise during devise production or use. These procedures comply with both FDA and ISO standard guidelines for risk management of medical devices.

The risk management process presented in ISO 14971 standard includes:

1) Identifying hazards and harmful conditions associated with a medical device that could put healthcare workers or patients at risk.

2) Evaluating the potential occurrence of such risks, and estimating the severity of the consequences.

3) Developing and implementing active safeguards within the device or the production process to control risks.

4) Regularly reviewing and monitoring the process to evaluate the effectiveness of risk management controls and the risk management process.

Our industry experts will follow a systematic approach and thoroughly document your every aspect of risk management system to provide evidence of your commitment to control risk throughout the entire life of a given medical device design.


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