Both risk management and post market surveillance (PMS) are key processes to monitor and maintain a medical device.
Risk management is a systematic process to identify, evaluate, and mitigate risks during the whole life cycle of a medical device. Post market surveillance (PMS) collects data about the medical device in the market, such as clinical data, incidents, market surveillance data, and feedback, which on the one hand input to risk management, and on the other may serve to evaluate the effectiveness of risk mitigations.
However, the interplay between risk management and PMS is more complex than this direct interface.
In the 5-minute guide below, our Head of Quality Dr. Dirk Hüber takes a brief look at how risk management and PMS interface and how to make this interface efficient and effective. You can view the guide in the screen reader below, or download at the button.
And should you have any risk management or PMS challenges related to medical devices, get in touch with our experts to find out how we can support your team.
