The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...
Global partnership will focus on providing customers with solutions to share reliable and proven product data with their business partners. SAN FRANCISCO – May 5, 2020 – PRLog — Innovit, a global software company specializing in UDI compliance...
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 4 technical amendments proposed last week by the European Council, without bringing additional...
On March 11, 2020, the World Health Organization designated “coronavirus disease 2019” (COVID-19) a global pandemic. As the number of cases worldwide continue to grow exponentially, social distancing has become the norm to slow the rate of transmission. The goal of...
Medical Device manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic, with many experiencing adverse impact to their supply chain and operations, their financial expectations and emergency response plans. The need...
