I agree that small design changes can have some of the biggest impacts on a medical device. One of the best ways to determine the effects are through risk assessment testing. Engineers should determin...

Packaging should be consider as equally important as the medical device itself. Even if the medical device meets all its specifications, it can be damaged in transport. Damaged medical devices are sus...

I think both verification and validation are important and one cannot exist without the other. Verification goes in hand with validation as if its not in the proper technical specifications it may not...

I understand everyone's thought that FDA is biased toward companies that pay them for expedited review, however, I think there are several misconceptions and also poor structure setup that attribute t...

I think this statement if fairly accurate by I disagree on having some diagnostic devices move from Class III into Class II. The reason behind this is that diagnostic devices drive life or death decis...

From my experience in industry I think making as little claims as possible is the ideal way to go. Anything that doesn't support the main claim or function of a product should be avoided and wording i...