I agree with most of the participants on the above post. ISO 14971, major regulation detailing the Risk Management Requirements for Medical Devices. Medical device manufacturers must have a good understanding of Risk Management Process including the Risk Management Plan should be part of the Quality Management System to obtain the ISO certification. There are four key points presented as part of the risk management process described in the ISO 14971.

1) Identifying hazards associated with medical device that could place patients at risk.
2) Estimating the potential occurrence of such risks, and evaluating the consequences.
3) Developing and implementing safeguards within the device or production process to control the risks.
4) Continuous monitoring of the process to assess the effectiveness of risk management process and risk management controls

All in all, each company must set up the above mentioned key things in order to be considered to have a risk management process.