Our Blog

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

Slider
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...