by Innovit Corporate Affairs | Sep 28, 2020 | Blog, GUDID
As a medical device manufacturer, you are required to submit product data to the GUDID in order meet UDI compliance requirements. If your company markets relatively few products in America, you may simply choose to do so by uploading spreadsheets directly to the...
by Innovit Corporate Affairs | Sep 23, 2020 | News
San Francisco, CA (September 23, 2020) Innovit, a global software company specializing in UDI compliance, Global Data Synchronization (GDSN), Master Data Management (MDM) and Product Information Management (PIM) solutions, has announced today that B. Braun Medical...
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 | 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 | 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...
