As a company specialising in the CE marking of medical devices, we have prepared a simple outline of this process. This makes it easier for medical device manufacturers to understand the various steps involved and we encourage you to contact us, whether you want to...
This week we celebrated the International Day of Women and Girls in Science, which takes place every year on 11 February. Scientific papers, medical devices, advances in robotics, astronomy or molecular genetics increasingly owe their progress to thousands of dedicated women. These 'new women scientists' are...
(Information update: Brexit and medical devices) Manufacturers of medical devices and medicines who are interested in finding out what the relationship between the European Union and the United Kingdom will be like after Brexit have at their disposal a publication produced by the European Medicines Agency...
Eudamed, the forthcoming medical device information database developed by the European Commission, already has a guide to clarify the nomenclature-related requirements to be met by manufacturers. The guide consists of two documents: A document covering the European Medical Device Nomenclature (EMDN), to be used by manufacturers once...
The new issue of the magazine of the professional institute for health studies (IPSalud) includes an interview with our CEO in which she explains all the ins and outs of the regulations related to medical products. The basic principles of our work at EpisKey Medical Consulting...
The European Commission has launched a call for observers to support the nomenclature subgroup of the Medical Device Coordination Group (MDCG). This call is made in order to ensure the necessary technical support for the nomenclature of medical devices. The observers' tasks will include advising the...
The launch of the surveillance system guidance is linked to a new version of the manufacturer's incident report (MIR) that will become mandatory in 2020. This new version introduces the use of the International Medical Device Regulators Forum (IMDRF) consensus adverse event terminology and coding...
[vc_row][vc_column][vc_column_text]On 3 May, the European Commission launched three consultation documents for medical device manufacturers, which include important information on the UDI (Unique Device Identifier) system for medical devices. Two of them include details on what information should be included for medical devices and in vitro...
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