Medical Device Consultant Tag

MDSAP-What Manufacturers Need to Know In 2014, the International Medical Device Regulators Forum (IMDRF) launched the Medical Device Single Audit Program (MDSAP) pilot. As of 2017, the MDSAP is in full force and fully operational. This poses the question, what do manufacturers...

Do you want the world to see your dirty laundry?  If not, then EMMA International can help you prepare for the new Medical Device Single Audit Program (MDSAP). MDSAP full implementation is in effect as of January 1, 2017. The Medical Device...

Like many industries, progress within the medical field depends on innovation. This innovation has produced novel technologies and medical device improvements that rely increasingly on data storage, software, networks, and user devices. The scale and severity of cyberattacks are on...

In 2007, several high-profile drug safety problems triggered Congress to mandate the FDA to develop an active surveillance system, utilizing electronic health data, to improve tracking and analysis of drug safety after drugs reach the market [1]. During the drug...