All you need to know about EUDAMED
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
Medical Device
ISO 20417 – all you need to know
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
Classification Rules under the MDR
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
Selling Medical Devices via an online shop
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
Who needs to get certified according to ISO 13485
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
Get the Max out of your consultant
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
Certification of Conformity
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
Declaration of Conformity
How to establish a compliant declaration of conformity The EC Declaration of Conformity (DoC) is the formal act of a manufacturer to declare that the… Read More »Declaration of Conformity
harmonised and consensus standards
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
custom-made vs. off-the-shelf
What you need to know when manufacturing custom-made medical devices Medical devices, and specifically implants, tend to become more and more patient-specific. Read here what… Read More »custom-made vs. off-the-shelf
