New Changes to the European Union’s Medical Device and In Vitro Diagnostic Device Regulations

On May 26, 2020, the European Union enacted new regulations concerning medical and in vitro diagnostic devices—a move that should cause manufacturers, clinical trial sponsors, investigators, and other regulated parties involved in medical device development, manufacture, and distribution in the EU to take notice. These new regulations replace existing directives and bring about many changes,…

Lessons Learned: Data Mapping Made Easier

The rate of information growth and their consumption are exponentially increasing within the business environment. If harnessed properly, businesses gain valuable insight through the depth and variety of information at their fingertips. However, on the heels of this growth come external threats and increased regulations. This unwanted attention and scrutiny elevate the need for a…