Medical Device Quality: Why Software Is More Challenging Than Hardware
The Impact of U.S. Regulation on Medical Device Innovation
Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.
Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel
For a company navigating a Class III medical device’s path to market, the U.S.
Four Questions to Help You Avoid Losing a CE Mark
A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it appli