by admin | Nov 29, 2017 | Latest News
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or...
by admin | Nov 29, 2017 | Latest News
The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means that the FDA has evaluated the tool and concurs with...
by admin | Nov 29, 2017 | Latest News
If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a major damper on your creativity and productivity in the design process,...
