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...
Nov 8 - 8:07
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...
Nov 6 - 3:31
The National Evaluation System for Health Technology Coordinating Center (NESTcc) announced this past Monday that they have selected eight real world evidence (RWE) test cases to properly assess medical device...
Oct 29 - 3:31
The International Coalition of Medicines Regulatory Authorities (ICRMA) announced on Friday that they are seeking industry experts for a one year project to ensure proper awareness of track and trace systems for...
