Module 16 2024

17/10/2024

What are the key objectives of post-market surveillance?

• Monitoring safety and performance:

It is the feedback systems used to gather real-world data/evidence which confirms the continued performance, safety and benefit of a medical device

• Risk management:

It allows manufacturers to identify emerging hazards/risks and to take appropriate action to ensure the benefit of a device continues to outweigh the risk

• Regulatory compliance:

It ensures that the devices remain compliant with the regulations and applicable safety/performance standards

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What are the key objectives of post-market surveillance?

• Continuous improvement:

Real-world data provides insights into a devices design, manufacture and usability that can drive product improvements

PMS is a set of critical processes used to maintain a high-standard of user and patient safety throughout a medical device's lifetime.

It is a moral imperative, and a legal requirement.

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