by Innovit Corporate Affairs | Sep 8, 2020 | Blog, Eudamed, GUDID
The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
by Innovit Corporate Affairs | Sep 2, 2020 | Blog
Mistake by Florida on child COVID-19 rate raises the question: Can Florida’s numbers be trusted? “It’s unacceptable to publish information that changes so dramatically that it warrants explanation, and then to not provide any explanation,” said...
by Innovit Corporate Affairs | Jul 7, 2020 | Blog, UDI
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...
by Innovit Corporate Affairs | May 5, 2020 | News
SAN FRANCISCO – May 5, 2020 – PRLog — Innovit, a global software company specializing in UDI compliance (Unique Device Identification), GDSN (Global Data Synchronization), MDM (Master Data Management) and PIM (Product Information Management)...
by Innovit Corporate Affairs | Apr 22, 2020 | Blog, MDR
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...