GUDID Data Submission Services: Potential Risks

GUDID Data Submission Services: Potential Risks

As a medical device manufacturer, you are required to submit product data to the GUDID in order to 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...
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...
EUDAMED and GUDID – What’s Changed?

EUDAMED and GUDID – What’s Changed?

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...