Introducing Innovit’s EUDAMED Reference Center

Introducing Innovit’s EUDAMED Reference Center

As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices.   Even the most experienced companies uncover critical gaps in...

Introducing Innovit’s EUDAMED Reference Center

As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices.   Even the most experienced companies uncover critical gaps in...
UDI Submission for China NMPA

UDI Submission for China NMPA

Although the regulatory process can be challenging due to rapid changes, bringing medical devices to the Chinese market is a potential high-growth area for many global manufacturers.  So, if you’re a medical device manufacturer doing business in China, it’s important...
EU-MDR Date of Application – Postponed…

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 4 technical amendments proposed last week by the European Council, without bringing additional...