The reason these standards cost money is because organizations like ISO and ASTM are non-profit bodies that fund their operations through the sale of their standards. They invest a lot of time and exp...

I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying and mitigating potential hazards before a product ...

A real life scenario of hazardous material causing significant harm would be in 2004 at the Centers for Disease Control and Prevention (CDC), where a serious lab safety breach took place. The hazard i...

Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled include modifications to the materials used, updat...

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical fr...

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical fr...

I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry toward stricter verification, documentation, and risk m...

Yes, I do feel safer knowing that validation and verification are applied to medical devices we use today and may rely on in the future. These processes make sure not only that a device is built corre...

The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using engineering standards, research, and benchmarking. Fo...

Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures the product meets the specifications outlined in t...

When design control is used insufficiently, several serious issues can arise during the development of a medical device. One major problem is that design requirements may not be clearly defined, leadi...

A company that comes to mind would be Theranos; the health technology company that claimed to have developed a revolutionary blood-testing device. The company allegedly manipulated and hid failed veri...

Yes, I definitely feel safer knowing that validation and verification are key and required steps in the development of medical devices. These processes ensure that devices not only meet design specifi...

In my opinion, double-blind studies are definitely the most reliable way to test how well a treatment actually works. While single-blind studies help reduce some bias, there’s still a chance that rese...

Researchers use several strategies to minimize the placebo effect and ensure their results accurately reflect a treatment’s true impact on the person's body. After doing some research, one common meth...