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Feeling Safer?

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(@elm33)
Posts: 39
Eminent Member
Topic starter
 

The past week we have learned about Validation and Verification. After learning about these two topics, do you feel safer knowing that these can be applied to medical devices that we use/may use in the future? Explain how and give an example. Personally I feel as though through many different types of testing, animal and clinical, that is what makes me feel safest when using a device.

 
Posted : 10/11/2024 10:38 pm
(@michael_patel)
Posts: 28
Eminent Member
 

Hi elm33,
Yes after this week's lecture and learning about validation and verification processes I do feel safer using medical devices. We learned that these steps are in place to ensure that devices meet strict design standards and work effectively in real-world conditions. From a patient's standpoint this gives some relief knowing there is care into what may potentially be interacting with your body. Verification checks the device’s specifications, catching design flaws early, while validation confirms it performs as intended for the end user. For instance, a pacemaker undergoes extensive testing to ensure it reliably regulates heart rhythms under various conditions.

 
Posted : 10/11/2024 10:45 pm
(@bsk32)
Posts: 51
Trusted Member
 

Hi elm33,

After this week's lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if the device will perform its intended function. Verification is there to test if the design inputs produce the required outputs, and make design changes as necessary. Validation is there to test on humans during clinical trials which shows that a lot of care is taken to ensure patient safety.

 
Posted : 10/11/2024 11:15 pm
 pmd5
(@pmd5)
Posts: 55
Trusted Member
 

I agree, after learning about verification and validation this week, I've gained so much knowledge about the safety and reliability of the medical devices we use. It definitely makes me feel much more confident in its safety and reliability. 

Verification makes sure that the device satisfies the specified design inputs, confirming that every product aspect has been tested against clear standards. This is important because it makes finding any possible problems or defects in the design on time easier before its application in real life.

Validation, in turn, seeks to establish whether the device does indeed work as it is intended to do when used by the end user. The goal here is to ensure that the device meets not only technical specifications but also indeed responds to patients' or real users' needs in practical conditions.

So having passed both the tests, it technically gives a guarantee about its safety and dependability as ultimately, these steps show that medical devices undergo careful and comprehensive testing

 
Posted : 10/11/2024 11:36 pm
(@zeinab-amoabediny)
Posts: 46
Trusted Member
 

Yes, understanding validation and verification gives me a lot more confidence in the safety of medical devices. Knowing that these processes are in place means that devices are rigorously checked not only to ensure they’re built correctly (verification) but also to confirm they perform safely and effectively in real-world scenarios (validation). This layered approach to testing significantly reduces the chance of a device malfunctioning or not meeting patient needs. An example is a pacemaker. In development, verification would involve tests to confirm the device’s electrical components, battery life, and programming are all working precisely as specified in the design. Engineers would check that each function, like heartbeat regulation, is technically sound. Then, in validation, the pacemaker would undergo animal testing and later human clinical trials to ensure it performs reliably in actual patients, maintaining heart rhythm effectively and safely over time.

 
Posted : 12/11/2024 3:30 pm
(@elm33)
Posts: 39
Eminent Member
Topic starter
 

I have come back to read all of your responses and totally agree with your points. I, too, feel a lot safer knowing that these steps are taken in order to really validate and verify product on the market. Having friends that have medical devices, I have also talked with them about the topic and I had found that most did not know the half of what developers do to the product that is implanted into their own body. They also felt that it gave them peace of mind knowing now the extent of testing that is done their own and on medical devices in general.

 
Posted : 11/12/2024 7:48 pm
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