The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
The Final Draft International Standard (FDIS) of ISO 10993-1 introduces the most significant updates in decades to the biological evaluation of medical devices. Among other things, these revisions reinforce a risk-based framework aligned with ISO 14971, expand expectations for particulate...
Consideration of human factors when designing a medical device should be a high priority. It is important that concerns regarding human factors are considered during the development phase of new medical devices. For many years, this phase of the process...
We may be seeing an increase in activity from medical device manufacturers as a result of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) which lifted the Medical Device Excise Tax for two years beginning January 1, 2016. Since January...
FDA announced new Office of Science and Engineering Laboratories (OSEL) Research Programs webpages. These webpages allow users to research by Clinical Area or by Special Topics. A few examples of searchable Clinical Areas are: Orthopedics, In Vitro Diagnostics (IVD), and...
