by Innovit Corporate Affairs | Oct 16, 2019 | Blog, Eudamed
EUDAMED deadlines remain unchanged – the go-live date is still March 26, 2020 with the Date of Application for device registration/submission standing at May 26, 2020. Yet, we’re nearing the end of 2019 with most med device companies still struggling to fully...
by Innovit Corporate Affairs | Sep 19, 2019 | Blog, UDI
If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation. Recent announcements suggest that PTC is...
by Innovit Corporate Affairs | Jul 24, 2019 | Blog, UDI
As a global software solution vendor in Life Sciences & Healthcare, our customers include many of the top medical device suppliers managing high volumes of product data and tens of thousands of device records. Based upon our experience helping customers with...
by Innovit Corporate Affairs | May 21, 2019 | Blog, UDI
Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...
by Innovit Product Team | Feb 26, 2019 | Blog, Eudamed, MDR
With a May 2021 go live date, The European Database for Medical Devices (EUDAMED) will be open to many more groups, including manufacturers, importers and sponsors. Current estimates are that this covers 70,000+ individual organizations and over 300,000 actual users....