The certification of medical machines is an extremely complex process which requires great competence and deep knowledge of the regulations relating to the certification of such machines, equipment or devices.
Redimec can rely on a network of certification laboratories; therefore, it can provide its customers with a full service from the medical device design stages to the complete certification of such device, regardless of its classification (class I, IIa, IIb and III).
As of now, Redimec can apply the new regulation EU 2017/745.
Besides providing the medical device certification service, Redimec is able to support machine users to create clean rooms in collaboration with leading companies experienced in manufacturing filtering systems and structures for clean rooms.
This allows the user to be freer to select structures and machines, saving more than 60% with respect to series productions.