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
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
First things first: Don’t get fooled about the Eudamed2 Database already being around in compliance with the Medical Device Directive MDD 93/42/EEC. The new EUDAMED… Read More »All you need to know about EUDAMED
When a manufacturer provides a medical device to the market, the manufacturer has to supply information with the device. As this is defined in EN… Read More »ISO 20417 – all you need to know
Being involved in countless projects and client interactions regarding questions to GACP, the following 5 most prominent myths are explained. Myth 1 – I can… Read More »5 Myths about GACP
understanding the classification rules The Medical Device Regulation (MDR) EU 2017/745 defines in its Annex VIII the classification rules for medical devices. Read here how… Read More »Classification Rules under the MDR
what you need to know Nowadays, online shops are a common source for buying all sorts of products and services. Thus, it’s a logical consequence… Read More »Selling Medical Devices via an online shop
Do I really need to get certified? Throughout our involved with many manufacturers of medical devices, suppliers, service providers, economic operators and design interested companies,… Read More »Who needs to get certified according to ISO 13485
So you hired a consultant? As you might be excited about the fact of having easily extended the workforce around the hiring freeze, you need… Read More »Get the Max out of your consultant
How to identify a original Certification of Compliance The EC Certification of Conformity (CoC) is the formal certification of a Notified Body (NB) in the… Read More »Certification of Conformity