How to create a UDI explained
The implementation and interpretation of the UDI system for medical devices and in-vitro devices gives rise to questions. Read here how the UDI is compiled… Read More »How to create a UDI explained
In-vitro diagnostics
What is the difference between eQMS and eDMS
You might have come across the terms electronic Quality Management System (eQMS) and electronic Document Management System (eDMS). But what exactly is the difference between… Read More »What is the difference between eQMS and eDMS
Regulatory Monitoring explained
Over the last weekend, 5 Standards have changed, 1 Guideline has been updated and 1 Regulation has come into force. Well, even though these change-rate… Read More »Regulatory Monitoring explained
Your guide to bullet-proof claims
Product Claims on the label are an important way to communicate the different aspects of the product and its use. But what if the claims… Read More »Your guide to bullet-proof claims
QMS for Distributors of medical devices
Economic operators or actors, as defined in the Medical Device Regulation (MDR) 2017/745 and In-Vitro Diagnostics medical device Regulation (IVDR) 2017/746 are not required to… Read More »QMS for Distributors of medical devices
Mine the gap – modern business process optimization
Data mining – which has evolved from a buzz-word to a real tool, can support in business process and procedure optimization. Learn here how this… Read More »Mine the gap – modern business process optimization
GTIN a potential alternative to the pharmacode and the UDI?
GTIN, the Global Trade Identification Number has attention in the health care industry and is on the rise. Does the GTIN offer a valuable alternative… Read More »GTIN a potential alternative to the pharmacode and the UDI?
How to read the SRN correctly
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostics… Read More »How to read the SRN correctly
All you need to know about Actors in EUDAMED
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostics… Read More »All you need to know about Actors in EUDAMED
Classification Rules under the IVDR
understanding the classification rules The In-Vitro Diagnostics Regulation (MDR) EU 2017/746 defines in its Annex VIII the classification rules for in-vitro diagnostics. Read here how… Read More »Classification Rules under the IVDR
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