EU-MDR Date of Application – Postponed…

The European Parliament has formally voted and adopted the amendment of its Medical Device Regulation (MDR) date of application. The Parliament has tabled and supported the four technical amendments proposed last week by the European Council, without additional...
GUDID and UDI – Are You Prepared?

GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier.  Unique Device Identification (UDI) is a system to mark and identify medical devices (via...

Healthcare Providers and COVID-19: Flattening the Curve

On March 11, 2020, the World Health Organization designated “coronavirus disease 2019” (COVID-19) a global pandemic. As the number of cases worldwide continues to grow exponentially, social distancing has become the norm to slow the rate of transmission. The goal of...