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...

read more

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...

read more

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...

read more

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...

read more

GUDID and UDI – Are You Prepared?

The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalogue for every medical device with an identifier. Unique Device Identification (UDI) is a system to mark and identify medical devices...

read more

Healthcare Providers and COVID-19: Flattening the Curve

On March 11, 2020, the World Health Organisation designated “coronavirus disease 2019” (COVID-19) a global pandemic. As the number of cases worldwide continue to grow exponentially, social distancing has become the norm to slow the rate of transmission. The goal, of...

read more