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 determine the results of each change and…   Read more»

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 susceptible to contamination or alter the functionality of the…   Read more»

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 work properly. Some things may need to…   Read more»

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 to this notion that “big pharma” or major corporations run…   Read more»

[quote data-userid=”35393″ data-postid=”24219″] One thing that I think could fit under this category are certain diagnostic tests that are currently listed as Class III. I think over time, some of these tests should be reconsidered to join Class II. This…   Read more»

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 is key. For example,…   Read more»