NEWS: EUDAMED State of Play: EU Commission delays EUDAMED Device Registration Go-live
The EU Commission provides a “EUDAMED playground” available for both manual web-based user access and automated M2M (machine to machine) Data Exchange for Actor Registration, Notified Bodies & Certificates, and Device Registration modules. These testing...
read morePart IV – Mayo Clinic: Improving Strategic Supply with Trusted Data
How triggering automated workflows in EHR systems with accurate clinical data ensures patient safety and transparency. Electronic medical (or health) records (EMR/EHRs) have had a positive effect on patient care and the work lives of healthcare providers. They can...
read morePart III – Mayo Clinic: Improving Strategic Supply with Trusted Data
Guaranteeing Supply for Critical Items During Extraordinary Events (e.g. COVID-19) No matter the circumstance – be it a regional natural disaster or worldwide pandemic - healthcare providers must be prepared to tackle supply shortages or supply chain delays. Doing so...
read morePart II – Mayo Clinic: Improving Strategic Supply with Trusted Data
Consistency of Categorisation to Facilitate Clinical Analysis There currently are over 20 different Classification and Nomenclature Systems used across the world for the classification of products in the healthcare sector which is used to group like products such as...
read morePart I – Mayo Clinic: Improving Strategic Supply with Trusted Data
Product Data Standardisation for Substitutes Analysis Healthcare providers are interested in maximising clinical performance and improving patient experience. So, choosing the right medical product for a given procedure is critical for caregivers to do their work...
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EUDAMED UPDATE: Actor Registration Module
European Commission just announced the availability of the EUDAMED Actor Registration module for voluntary, production use by Member States and Economic Operators. The EUDAMED database is a key enabling feature (central database and collaboration tool) of the new...
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M2M Testing – What it means and why it’s important.
Medical Device Regulation (MDR) is a set of recent European regulations aimed to enhance patient safety and modernise public health. Published in May 2017 by the European Commission (EU COM), they are an overhaul and expansion of the MDD (Medical Device Directives)...
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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...
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How Does the GDSN Work?
Globally, the medical device manufacturing sector continues to grow steadily due to ageing populations in developed economies, growing health concerns and the acceleration of digital health. But like any industry, growth requires the ability to seize opportunities...
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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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