Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this...
Established in 1976, a 510(k) is a “premarket submission made to FDA [by medical device manufacturers] to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially...
Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting...