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Risk Management

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What are some critical characteristics of the risk profile of a medical device?

Topic starter Posted : 13/04/2022 1:18 am
Eminent Member Registered

One important characteristic of developing a solid risk profile is establishing design controls intended to demonstrate that a medical device has been designed to address the needs of users and patients, designed to meet inputs and requirements, proven to meet applicable standards, meets performance criteria. With Design Controls that prove your medical device is safe for use will allow risk management to identify, evaluate, analyze, assess, and mitigate potential product issues according to these. There is a very strong correlation and relationship between Design Controls and Risk Management as they address design, development, and manufacturing of medical devices just from slightly different perspectives. However, it shouldn't be limited to just design controls.


Erbay Dallı, Ö., Ceylan, İ., & Kelebek Girgin, N. (2022). Incidence, characteristics and risk factors of medical device-related pressure injuries: An observational cohort study. Intensive & critical care nursing69, 103180.

Posted : 16/04/2022 9:46 am
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risks can range in many but aren't limited to faulty equipment and other hazards, medical malpractice, and procedures. Managing these and other risks is pivotal within the health care industry to keep people safe and secure, and to keep costs down. Once risk management strategies are put into place, hospitals, long-term care facilities, and other health care organizations can minimize the potential for loss.

Posted : 16/04/2022 10:33 pm