We assist companies with everything related to regulations, standards and obtaining the CE marking for their medical device and/or machine.
Moreover, in addition to/apart from the marking process (depending on whether or not they are manufacturers) we help them to familiarise themselves with the standards and laws that they must comply with for the commercialisation of their product and the implementation of management standards such as: ISO 13485, ISO 9001, 14001, 48001, various UNE standards, etc.).
To provide a comprehensive service for medical devices, we can perform the functions of the technicians and staff responsible for complying with the regulations (which is compulsory for all such devices).
Alava Technology Park
Albert Einstein 15, 129-131
01510 Vitoria-Gasteiz (Alava)
(+34) 616 969 920