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...
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Optical Medical Device Manufacturers – GUDID & UDI – Are You Prepared?
Global Ophthalmic Medical Devices – Meeting Market Demands According to the Vision Council of America, approximately 75% of adults use some sort of vision correction. With the increasing adoption of contact lenses and spectacles, coupled with the rising number of...
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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Medical Device Manufacturing and COVID-19: Challenges and Opportunities
Medical Device Manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic, with many experiencing an adverse impact on their supply chain and operations, their financial expectations and emergency response plans. The need...
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