A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this seventh installment of a 10-part series, the experts address the use of SMEs – subject matter experts – during inspections.
A panel of longtime industry experts recently convened to give manufacturers advice on the 10 best and worst things they could do during an inspection by the US Food and Drug Administration.
Offering tips in Part 7 of our series is David Elder, executive VP for consulting firm Greenleaf Health, and a...
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
