I agree with previous posts like @asimbana mentions that validation is important to determine if device meets user needs and it’s intended use. I like @williamzembricki‘s comment “When in doubt, validate”. I agree that it is necessary for most cases especially with medical devices for validation to be done. Validation is key in determining and testing that the device meets the user needs, and you want to make sure your company is putting out a quality product and following the necessary steps to ensure that especially for medical devices. It can be costly if the appropriate validation isn’t performed. I came across this interesting article from earlier in October in New York Times about how Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years. $1.5 B is very big number, the article goes on to say that in the past five to six years, more than 200 cardiac devices have been recalled. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration. Overall, I think Validation is an important step as everyone has mentioned above and is a useful part in the earlier stages before production. No one wants a faulty heart device, that’s costly for everyone involved.

Having trouble adding the link: NY Times October 2, 2017 article Replacing Faulty Heart Devices Costs Medicare $1.5 Billion in 10 Years