In-vitro diagnostics

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

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

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

harmonised standards and consensus standards Developing a medical device will bring you and your team to the terms of harmonised and consensus standards. Read here… Read More »harmonised and consensus standards

How to best set claims for a medical device Claims for a regulated product are the promise to the user for its performance, safety, and… Read More »How to best set claims for a medical device

All you need to know about Common Specifications The new regulations for medical devices (MDR 2017/745) and in-vitro diagnostics (IVDR 2017/746) state common specifications. Even… Read More »What you need to know about Common Specifications

DHF, DMR, MDF, DHR – what do these terms stand for? When developing medical devices, you will come across specific terms especially when aiming for… Read More »DHF, DMR, MDF, DHR – what do these terms stand for?