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...
Making Decisions in a COVID-19 World: Why Trusted Data Matters

Making Decisions in a COVID-19 World: Why Trusted Data Matters

  Mistake by Florida on child COVID-19 rate raises the question: Can Florida’s numbers be trusted?   “It’s unacceptable to publish information that changes so dramatically that it warrants explanation, and then to not provide any explanation,” said Jason Salemi,...
FDA Delays UDI Deadline for Class I Devices to September 2022

FDA Delays UDI Deadline for Class I Devices to September 2022

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...