Medical Device Risk Analysis & Periodic Review|Risk Management Plan|ISO14971:2019 Risk Standards|IVD

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Medical Device Risk Analysis & Periodic Review|Risk Management Plan|ISO14971:2019 Risk Standards|IVD@ivdmanufacturing7208

Risk management in medical devices is the process of identifying, understanding, and controlling potential hazards that could arise from the use of a medical device. The goal of risk management is to ensure the safety of patients and minimize harm.
Here are some key aspects of risk management for medical devices:
Risk analysis
A structured tool that helps identify and evaluate potential problems that could arise from using a medical device.
Risk management file
A record of all information related to risk, including post-production situations.
Risk management process
Covers the entire life cycle of the device, from conception to decommissioning.
Risk evaluation
Balances the risks of a medical device against the anticipated benefits to the user.
Post-market surveillance
A key part of risk management that involves capturing and using data to monitor and update risk management files

List of Queries-

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