Part IV – Mayo Clinic: Improving Strategic Supply with Trusted Data

Part III – Mayo Clinic: Improving Strategic Supply with Trusted Data

Part II – Mayo Clinic: Improving Strategic Supply with Trusted Data

Part I – Mayo Clinic: Improving Strategic Supply with Trusted Data

EUDAMED: Playground Testing Update

EUDAMED go-live date is still scheduled for May 2022.  In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web‑based user access and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies and Device Registration modules.  Three solution providers – including Innovit […]

How Does the GDSN Work?

Globally, the medical device manufacturing sector continues to grow steadily due to aging populations in developed economies, growing health concerns and the acceleration of digital health.  But like any industry, growth requires the ability to seize opportunities within expanding market channels.  And this expansion – more products in more regions – requires data exchange, and […]

GUDID Data Submission Services: 3 Potential Risks

As a medical device manufacturer, you are required to submit product data to the GUDID in order 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 GUDID portal.  But if your product range is larger, say more than […]

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.    And with the rising number of retail chain stores, optometrists and opticians, the global vision care devices and equipment market (valued at about $27.6 billion in 2018) is expected to […]

UDI Submission for China NMPA

Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market.  It is a potential high-growth area for many global medical device manufacturers.  So, if you’re a medical device manufacturer doing business in China, it’s important that you’re up‑to‑date on the following UDI regulation. […]

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 Eurozone.  The EUDAMED system was stipulated under EU MDR to serve as a repository for important clinical information about medical […]

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