There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.
Compliant, noncompliant and semi-compliant balloons—which one is right for you? Read to know how to choose the right manufacturing process for your silicone medical balloon.