EUDAMED State of Play – New Playground Available for EUDAMED Device Registration and NBs & Certificates modules
What’s New? EUDAMED go-live date is still scheduled for May 2022. But you may recall that in order to ensure a smooth and effective implementation, the EU Commission provides a “EUDAMED playground.” It’s currently available for both manual web- based user access,...
Innovit Q&A: M2M Testing – What it means and why it’s important.
Medical Device Regulation (MDR) are a set of recent European regulations aimed to enhance patient safety and modernize public health. Published in May 2017 by the European Commission (EU COM), they are an overhaul and expansion of the MDD (Medical Device Directives)...
Part 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...
Part III – Mayo Clinic: Improving Strategic Supply with Trusted Data
Guaranteeing Supply for Critical Items During Extraordinary Events (e.g. COVID-19) No matter what the circumstance – be it regional natural disaster or worldwide pandemic - healthcare providers must be prepared to tackle supply shortages or supply chain...
Part II – Mayo Clinic: Improving Strategic Supply with Trusted Data
Consistency of Categorization 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 are used to group like products...
Part I – Mayo Clinic: Improving Strategic Supply with Trusted Data
Product Data Standardization for Substitutes Analysis Healthcare providers are interested in maximizing clinical performance and improving patient experience. So, choosing the right medical product for a given procedure is critical for caregivers to do their...
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...
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...
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...
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...