Jan 9 - 8:17
On Thursday December 27th, Health Canada detailed a new three-part method aimed to help safety, oversight and quality in the Canadian medical device market. This plan has come soon after the investigation of the...
Jan 8 - 8:08
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These...
Dec 19 - 8:16
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These...
Dec 12 - 8:50
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...
Dec 3 - 8:49
“Since the President’s Emergency Plan for AIDS Relief (PEPFAR) was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently over 14 million people living...
Nov 26 - 9:27
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...
